FDA 510(k) Applications for Medical Device Product Code "JJY"
(Multi-Analyte Controls, All Kinds (Assayed))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K143573 | AALTO SCIENTIFIC LTD. | Audit MicroControls Linearity FD Tumor Markers II | 01/16/2015 |
| K142978 | AALTO SCIENTIFIC LTD. | Audit MicroControls Linearity LQ Special Diabetes | 11/20/2014 |
| K032122 | AALTO SCIENTIFIC LTD. | AUDIT MICROCONTROLS MICROFD BNP CONTROL | 09/09/2003 |
| K100718 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 | 09/03/2010 |
| K102617 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV CARDIAC MARKERS LINEARITY SET | 01/10/2011 |
| K042318 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET | 12/09/2004 |
| K062668 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV IMMUNOASSAY LINEARITY SET | 10/16/2006 |
| K103601 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV IMMUNOASSAY LINEARITY SET | 06/10/2011 |
| K070223 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV LIPIDS LINEARITY SET (LOW) | 03/13/2007 |
| K101216 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV PROTEIN LINEARITY SET | 01/14/2011 |
| K101226 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV RF/CRP LINEARITY SET | 08/31/2010 |
| K130762 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET | 04/29/2013 |
| K082714 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 | 11/19/2008 |
| K082717 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 | 10/30/2008 |
| K111964 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY | 03/02/2012 |
| K112742 | AALTO SCIENTIFIC LTD. | AUDIT MICROLQ SPINAL FLUID CONTROL | 06/15/2012 |
| K112705 | AALTO SCIENTIFIC LTD. | AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL | 01/24/2012 |
| K163629 | Aalto Scientific, Ltd. | Audit MicroControls Linearity FD Tumor Markers II | 03/10/2017 |
| K992710 | ABBOTT LABORATORIES | ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK | 11/24/1999 |
| K102700 | ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN | LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS | 12/21/2010 |
| K974822 | AVL SCIENTIFIC CORP. | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | 01/22/1998 |
| K001632 | AVL SCIENTIFIC CORP. | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | 06/19/2000 |
| K030452 | BAYER DIAGNOSTICS CORP. | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | 03/03/2003 |
| K033379 | BAYER DIAGNOSTICS CORP. | BAYER SPECIAL CHEMISTRY CONTROLS | 12/19/2003 |
| K061137 | BAYER HEALTHCARE, LLC | ADVIA IMS CPSA CONTROL | 07/06/2006 |
| K030801 | BAYER HEALTHCARE, LLC | BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL | 04/09/2003 |
| K031644 | BAYER HEALTHCARE, LLC | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL | 06/25/2003 |
| K013235 | BECKMAN COULTER, INC. | MODIFICATION TO SYNCHRON CONTROL | 10/16/2001 |
| K020521 | BECKMAN COULTER, INC. | MODIFICATION TO VIGIL LIPID CONTROL | 03/01/2002 |
| K003488 | BECKMAN COULTER, INC. | SYNCHRON CONTROL | 11/27/2000 |
| K993023 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS | 11/26/1999 |
| K982224 | BECKMAN COULTER, INC. | VIGIL PROTEIN CONTROL | 07/09/1998 |
| K010358 | BECKMAN COULTER, INC. | VIGIL SEROLOGY CONTROL LEVEL C | 03/05/2001 |
| K974452 | BECKMAN INSTRUMENTS, INC. | VIGIL LIPID CONTROL | 12/17/1997 |
| K964065 | BEHRING DIAGNOSTICS, INC. | N/T PROTEIN CONTROL SL | 11/06/1996 |
| K955858 | BEHRING DIAGNOSTICS, INC. | N/T PROTEIN CONTROL SY/L, M AND H | 02/21/1996 |
| K990317 | BIO-RAD | ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 | 03/18/1999 |
| K990017 | BIO-RAD | ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 | 01/25/1999 |
| K990282 | BIO-RAD | ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 | 03/09/1999 |
| K990161 | BIO-RAD | ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 | 01/28/1999 |
| K990424 | BIO-RAD | ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 | 03/31/1999 |
| K990150 | BIO-RAD | ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 | 01/26/1999 |
| K990149 | BIO-RAD | ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 | 01/26/1999 |
| K990391 | BIO-RAD | ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 | 03/15/1999 |
| K990394 | BIO-RAD | ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 | 03/18/1999 |
| K990610 | BIO-RAD | ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 | 04/27/1999 |
| K011853 | BIO-RAD | ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 | 07/17/2001 |
| K984325 | BIO-RAD | ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 | 12/17/1998 |
| K984074 | BIO-RAD | ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 | 11/20/1998 |
| K000875 | BIO-RAD | ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 | 04/20/2000 |
| K050537 | BIO-RAD | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS | 04/27/2005 |
| K961941 | BIO-RAD | LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 | 09/16/1996 |
| K001373 | BIO-RAD | LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 | 05/25/2000 |
| K992550 | BIO-RAD | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 | 08/11/1999 |
| K022991 | BIO-RAD | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 | 09/17/2002 |
| K011494 | BIO-RAD | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL | 06/08/2001 |
| K012513 | BIO-RAD | LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 | 08/29/2001 |
| K002460 | BIO-RAD | LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 | 08/31/2000 |
| K984225 | BIO-RAD | LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 | 12/14/1998 |
| K965171 | BIO-RAD | LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) | 01/13/1997 |
| K971954 | BIO-RAD | LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) | 06/11/1997 |
| K043208 | BIO-RAD | LIQUID ASSAYED MULTIQUAL CONTROL | 01/07/2005 |
| K011867 | BIO-RAD | LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 | 07/12/2001 |
| K992741 | BIO-RAD | LYPHOCHEK ANEMIA CONTROL, MODEL 500 | 11/09/1999 |
| K042324 | BIO-RAD | LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 | 10/07/2004 |
| K002196 | BIO-RAD | LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 | 08/07/2000 |
| K971952 | BIO-RAD | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) | 06/16/1997 |
| K981532 | BIO-RAD | LYPHOCHEK IMMUNOASSAY PLUS CONTROL | 05/12/1998 |
| K984594 | BIO-RAD | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 | 02/02/1999 |
| K011579 | BIO-RAD | LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 | 06/26/2001 |
| K983807 | BIO-RAD | LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 | 12/16/1998 |
| K992172 | BIO-RAD | LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 | 09/02/1999 |
| K984477 | BIO-RAD | LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 | 01/29/1999 |
| K990888 | BIO-RAD | MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 | 04/07/1999 |
| K050536 | BIO-RAD | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL | 03/24/2005 |
| K033387 | BIO-RAD | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | 12/02/2003 |
| K042815 | BIO-RAD | QUEST TUMOR MARKER CONTROL, MODEL 955 | 11/05/2004 |
| K150300 | Bio-Rad Laboratories | Liquichek Cardiac Markers Plus Control LT | 12/11/2015 |
| K140916 | Bio-Rad Laboratories | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | 05/06/2014 |
| K123198 | Bio-Rad Laboratories | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA | 11/20/2012 |
| K132227 | Bio-Rad Laboratories | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY | 10/25/2013 |
| K130761 | Bio-Rad Laboratories | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK | 04/12/2013 |
| K140764 | Bio-Rad Laboratories | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | 04/25/2014 |
| K143379 | Bio-Rad Laboratories | Liquichek Maternal Serum II Control | 03/13/2015 |
| K123775 | Bio-Rad Laboratories | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK | 01/31/2013 |
| K071675 | Bio-Rad Laboratories | LIQUICHEK TUMOR MARKER CONTROL | 07/03/2007 |
| K141073 | Bio-Rad Laboratories | LIQUICHEK TUMOR MARKER CONTROL | 06/23/2014 |
| K163015 | BIO-RAD LABORATORIES | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | 01/10/2017 |
| K122838 | Bio-Rad Laboratories | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK | 10/17/2012 |
| K130162 | Bio-Rad Laboratories | LIQUID ASSAYED MULTIQUAL PREMIUM | 03/01/2013 |
| K123663 | Bio-Rad Laboratories | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | 12/27/2012 |
| K134013 | Bio-Rad Laboratories | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | 04/24/2014 |
| K082036 | Bio-Rad Laboratories | LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK | 09/08/2008 |
| K133960 | Bio-Rad Laboratories | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | 01/22/2014 |
| K073080 | Bio-Rad Laboratories | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | 01/24/2008 |
| K042335 | BIO-RAD LABORATORIES, INC. | ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 | 09/17/2004 |
| K040277 | BIO-RAD LABORATORIES, INC. | LIQUICHEK CARDIAC MARKER CONTROL LT | 03/10/2004 |
| K130963 | BIO-RAD LABORATORIES, INC. | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK | 05/06/2013 |
| K043108 | BIO-RAD LABORATORIES, INC. | LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL | 12/07/2004 |
| K040822 | BIO-RAD LABORATORIES, INC. | LIQUICHEK TORCH PLUS IGM CONTROL | 05/19/2004 |
| K020817 | BIO-RAD LABORATORIES, INC. | LIQUICHEK URINE CHEMISTRY CONTROL | 04/12/2002 |
| K040273 | BIO-RAD LABORATORIES, INC. | LYPHOCHEK ASSAYED CHEMISTRY CONTROL | 03/04/2004 |
| K022041 | BIO-RAD LABORATORIES, INC. | LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 | 07/16/2002 |
| K072835 | BIO-RAD, DIAGNOSTICS GRP. | LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK | 12/11/2007 |
| K121794 | BIO-RAD, DIAGNOSTICS GRP. | LIQUICHEK URINE CHEMISTRY CONTROL | 07/11/2012 |
| K100727 | BIO-RAD, DIAGNOSTICS GRP. | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK | 09/14/2010 |
| K963770 | BIOCIRCUITS CORP. | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS | 12/05/1996 |
| K012431 | BIONOSTICS, INC. | COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 | 08/28/2001 |
| K021930 | BIONOSTICS, INC. | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL | 06/25/2002 |
| K980178 | BIONOSTICS, INC. | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY | 02/12/1998 |
| K032453 | BIONOSTICS, INC. | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL | 08/28/2003 |
| K972868 | BIONOSTICS, INC. | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL | 08/28/1997 |
| K961359 | BIOPROCESSING, INC. | LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 | 09/13/1996 |
| K060850 | BIORESOURCE TECHNOLOGY, INC. | NOD CHEMISTRY CONTROL | 05/30/2006 |
| K040352 | BIORESOURCE TECHNOLOGY, INC. | NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) | 04/02/2004 |
| K030088 | BIOSITE INCORPORATED | TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS | 01/17/2003 |
| K030089 | BIOSITE INCORPORATED | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS | 01/23/2003 |
| K040459 | BIOSITE INCORPORATED | TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS | 07/06/2004 |
| K093032 | BIOSITE INCORPORATED | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | 11/13/2009 |
| K072892 | BIOSITE INCORPORATED | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | 12/07/2007 |
| K974827 | BIOSITE INCORPORATED | TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE | 01/08/1998 |
| K974613 | BLACKHAWK BIOSYSTEMS, INC. | VIROTROL III | 01/27/1998 |
| K974826 | BOEHRINGER MANNHEIM CORP. | BM PRECIPATH(R) HDL/LDL-C CONTROL | 01/22/1998 |
| K983492 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC | 10/09/1998 |
| K981401 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS | 05/18/1998 |
| K974384 | BOEHRINGER MANNHEIM CORP. | ELECSYS CALCHECK FOLATE | 12/08/1997 |
| K983166 | BOEHRINGER MANNHEIM CORP. | ELECSYS CALCHECK MYOGLOBIN | 09/22/1998 |
| K970147 | BOEHRINGER MANNHEIM CORP. | ELECSYS CALCHECK PROLACTIN | 02/10/1997 |
| K984372 | BOEHRINGER MANNHEIM CORP. | ELECSYS CALCHECK TROPONIN T | 12/14/1998 |
| K984419 | BOEHRINGER MANNHEIM CORP. | ELECSYS IGE CALCHECK | 02/02/1999 |
| K962575 | BOEHRINGER MANNHEIM CORP. | ELECSYS PRECICONTROL CARDIAC | 07/22/1996 |
| K972235 | BOEHRINGER MANNHEIM CORP. | PRECICONTROL TUMOR MARKER 1 AND 2 | 08/12/1997 |
| K973629 | BOEHRINGER MANNHEIM CORP. | PRECINORM RF, PRECIPATH RF | 10/07/1997 |
| K972048 | BOSTON BIOMEDICA, INC. | ACCURUN 117 HBEAG POSITIVE CONTROL | 08/12/1997 |
| K972307 | BOSTON BIOMEDICA, INC. | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL | 08/07/1997 |
| K971406 | BOSTON BIOMEDICA, INC. | ACCURUN 120 HAV IGG POSITIVE CONTROL | 08/07/1997 |
| K971657 | BOSTON BIOMEDICA, INC. | ACCURUN 121 HAV IGM POSITIVE CONTROL | 08/12/1997 |
| K964640 | CANYON DIAGNOSTICS, INC. | CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 | 12/13/1996 |
| K962630 | CASCO STANDARDS | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL | 07/22/1996 |
| K961750 | CASCO STANDARDS | DOCUMENT CARDIAC ASSAYED CONTROL | 07/22/1996 |
| K972904 | CASCO STANDARDS | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL | 02/20/1998 |
| K002174 | CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) | DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 | 08/22/2000 |
| K992034 | CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) | DOCUMENT THYROID CAL*VER | 07/23/1999 |
| K993014 | CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) | MODIFICATION TO DOCUMENT THYROID CAL.VER | 11/26/1999 |
| K970956 | CHIRON DIAGNOSTICS CORP. | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 | 04/08/1997 |
| K970979 | CHIRON DIAGNOSTICS CORP. | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 | 04/02/1997 |
| K971071 | CHIRON DIAGNOSTICS CORP. | LIQUID LIGAND 1,2,3 | 04/23/1997 |
| K971405 | CHIRON DIAGNOSTICS CORP. | SPECIALITY URINE 1,2 | 06/16/1997 |
| K012855 | CLINICAL CONTROLS DIVISION | LIQUISPX LIQUID LIPID CONTROL | 08/30/2001 |
| K955690 | CLINICAL CONTROLS, INC. | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | 04/24/1996 |
| K955691 | CLINICAL CONTROLS, INC. | SERUM VOLATILES CONTROL LEVEL 1 & 2 | 04/24/1996 |
| K080973 | CLINIQA CORPORATION | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | 06/02/2008 |
| K062916 | CLINIQA CORPORATION | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | 10/23/2006 |
| K061182 | CLINIQA CORPORATION | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | 05/25/2006 |
| K030705 | CLINIQA CORPORATION | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL | 03/26/2003 |
| K070741 | CLINIQA CORPORATION | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | 05/04/2007 |
| K082107 | CLINIQA CORPORATION | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | 09/17/2008 |
| K083554 | CLINIQA CORPORATION | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | 04/21/2009 |
| K031921 | CLINIQA CORPORATION | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS | 08/25/2003 |
| K033162 | CLINIQA CORPORATION | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | 10/10/2003 |
| K040535 | CLINIQA CORPORATION | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS | 03/29/2004 |
| K032074 | CLINIQA CORPORATION | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS | 10/21/2003 |
| K040091 | CLINIQA CORPORATION | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | 02/23/2004 |
| K022936 | CLINIQA CORPORATION | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE | 10/02/2002 |
| K031577 | CLINIQA CORPORATION | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS | 08/06/2003 |
| K031575 | CLINIQA CORPORATION | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS | 07/23/2003 |
| K023250 | CLINIQA CORPORATION | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE | 10/17/2002 |
| K022867 | CLINIQA CORPORATION | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE | 10/02/2002 |
| K030566 | CLINIQA CORPORATION | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS | 03/13/2003 |
| K022885 | CLINIQA CORPORATION | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE | 10/02/2002 |
| K030150 | CLINIQA CORPORATION | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS | 01/28/2003 |
| K013332 | CLINIQA CORPORATION | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE | 11/20/2001 |
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