FDA 510(k) Applications Submitted by Bio-Rad

FDA 510(k) Number Submission Date Device Name Applicant
K060641 03/10/2006 PLATELIA ASPERGILLUS EIA, MODEL 62793 BIO-RAD
K013839 11/19/2001 BIO-RAD PLATELIA TOXO IGG TMB BIO-RAD
K013837 11/19/2001 BIO-RAD PLATELIA TOXO IGM TMB BIO-RAD
K023857 11/20/2002 PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 BIO-RAD
K093678 11/27/2009 PLATELIA ASPERGILLUS EIA MODEL 62793 BIO-RAD
K011494 05/15/2001 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL BIO-RAD
K972174 06/09/1997 LYPHOCHEK REMEDI CONTROL BIO-RAD
K011853 06/13/2001 ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 BIO-RAD
K011867 06/14/2001 LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 BIO-RAD
K955153 11/13/1995 LYPHOCHEK BENZO/TCA CONTROL-SET B BIO-RAD
K021415 05/03/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 BIO-RAD
K021414 05/03/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 BIO-RAD
K021411 05/03/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 BIO-RAD
K990017 01/04/1999 ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 BIO-RAD
K030182 01/17/2003 LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 BIO-RAD
K990149 01/19/1999 ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 BIO-RAD
K990150 01/19/1999 ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 BIO-RAD
K990161 01/19/1999 ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 BIO-RAD
K990162 01/19/1999 ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 BIO-RAD
K990282 01/29/1999 ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 BIO-RAD
K990317 01/29/1999 ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 BIO-RAD
K040275 02/05/2004 LYPHOCHEK HEMOSTASIS CONTROL BIO-RAD
K990394 02/09/1999 ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 BIO-RAD
K990393 02/09/1999 ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 BIO-RAD
K990391 02/09/1999 ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 BIO-RAD
K990424 02/11/1999 ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 BIO-RAD
K980556 02/13/1998 LIQUICHEK CARDIAC MARKERS CONTROL LT BIO-RAD
K980871 02/19/1998 LYPHOCHEK WHOLE BLOOD CONTROL BIO-RAD
K990587 02/23/1999 ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 BIO-RAD
K970666 02/24/1997 LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL BIO-RAD
K990610 02/24/1999 ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 BIO-RAD
K990608 02/24/1999 ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 BIO-RAD
K990888 03/10/1999 MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 BIO-RAD
K960987 03/11/1996 LIQUICHEK RHEUMATOID FACTOR CONTROL BIO-RAD
K990858 03/15/1999 LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 BIO-RAD
K990928 03/19/1999 LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 BIO-RAD
K000875 03/20/2000 ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 BIO-RAD
K000874 03/20/2000 URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 BIO-RAD
K031231 04/18/2003 LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS BIO-RAD
K981532 04/29/1998 LYPHOCHEK IMMUNOASSAY PLUS CONTROL BIO-RAD
K001373 05/01/2000 LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 BIO-RAD
K021384 05/02/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 BIO-RAD
K981590 05/04/1998 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON BIO-RAD
K971691 05/07/1997 LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 BIO-RAD
K961828 05/13/1996 LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) BIO-RAD
K961941 05/20/1996 LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 BIO-RAD
K971952 05/28/1997 LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) BIO-RAD
K971954 05/28/1997 LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) BIO-RAD
K041457 06/01/2004 LIQUICHEK HEMATOLOGY CONTROL (A) BIO-RAD
K992172 06/28/1999 LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 BIO-RAD
K002120 07/13/2000 LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 BIO-RAD
K002196 07/20/2000 LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 BIO-RAD
K992550 07/30/1999 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 BIO-RAD
K022529 07/31/2002 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 BIO-RAD
K022525 07/31/2002 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 BIO-RAD
K002460 08/10/2000 LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 BIO-RAD
K022707 08/14/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 BIO-RAD
K992741 08/16/1999 LYPHOCHEK ANEMIA CONTROL, MODEL 500 BIO-RAD
K002535 08/16/2000 LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 BIO-RAD
K002536 08/16/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) BIO-RAD
K992781 08/19/1999 ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 BIO-RAD
K002866 09/13/2000 LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 BIO-RAD
K002865 09/13/2000 LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 BIO-RAD
K003030 09/28/2000 LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET BIO-RAD
K042815 10/12/2004 QUEST TUMOR MARKER CONTROL, MODEL 955 BIO-RAD
K983578 10/13/1998 ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 BIO-RAD
K042836 10/14/2004 LIQUICHEK RETICULOCYTE CONTROL (A) BIO-RAD
K042837 10/14/2004 LIQUICHEK ELEVATED CRP CONTROL BIO-RAD
K003242 10/17/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 BIO-RAD
K003239 10/17/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 BIO-RAD
K983807 10/28/1998 LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 BIO-RAD
K984071 11/16/1998 LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 BIO-RAD
K984073 11/16/1998 ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 BIO-RAD
K984074 11/16/1998 ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 BIO-RAD
K984072 11/16/1998 ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 BIO-RAD
K984070 11/16/1998 ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 BIO-RAD
K984225 11/25/1998 LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 BIO-RAD
K984318 12/03/1998 ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 BIO-RAD
K984319 12/03/1998 ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 BIO-RAD
K984323 12/03/1998 ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 BIO-RAD
K984324 12/03/1998 ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 BIO-RAD
K984325 12/03/1998 ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 BIO-RAD
K984327 12/03/1998 ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 BIO-RAD
K984396 12/09/1998 LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 BIO-RAD
K984397 12/09/1998 LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 BIO-RAD
K984399 12/09/1998 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 BIO-RAD
K984400 12/09/1998 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 BIO-RAD
K984398 12/09/1998 LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 BIO-RAD
K964963 12/11/1996 LYPHOCHEK COAGULATION CONTROL BIO-RAD
K984475 12/16/1998 LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 BIO-RAD
K984473 12/16/1998 LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 BIO-RAD
K984470 12/16/1998 LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 BIO-RAD
K984464 12/16/1998 LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 BIO-RAD
K984479 12/16/1998 LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 BIO-RAD
K984478 12/16/1998 LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 BIO-RAD
K984462 12/16/1998 LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 BIO-RAD
K984477 12/16/1998 LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 BIO-RAD
K984476 12/16/1998 LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 BIO-RAD
K965171 12/24/1996 LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) BIO-RAD
K984594 12/28/1998 LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 BIO-RAD
K984626 12/28/1998 ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 BIO-RAD
K984625 12/28/1998 ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 BIO-RAD
K984604 12/28/1998 ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 BIO-RAD
K993536 10/19/1999 BIO-RAD CODA NEONATAL GALT ASSAY BIO-RAD
K080012 01/03/2008 PLATELIA LYME IGG ASSAY BIO-RAD
K070361 02/07/2007 MRSASELECT BIO-RAD
K100589 03/02/2010 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS BIO-RAD
K081212 04/29/2008 MRSASELECT - EXTENDED INCUBATION BIO-RAD
K081362 05/15/2008 PLATELIA LYME IGM BIO-RAD
K122187 07/24/2012 VRESELECT CULTURE MEDIUM BIO-RAD
K103684 12/17/2010 VRESELECT CULTURE MEDIUM BIO-RAD
K003280 10/19/2000 VARIANT II TOTAL GHB BIO-RAD
K960392 01/29/1996 CDM BIO-RAD
K972024 06/02/1997 CODA AUTOMATED EIA ANALYZER BIO-RAD
K972609 07/11/1997 VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM BIO-RAD
K963018 08/02/1996 BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS BIO-RAD
K990827 03/12/1999 MICROPLATE NEONATAL GALT ASSAY BIO-RAD
K991127 04/02/1999 VARIANT II B-THALASSEMIA BIO-RAD
K984268 11/30/1998 VARIANT II HEMOGLOBIN A1C PROGRAM BIO-RAD
K955355 11/21/1995 VARIANT ALPHA-THALASSEMIA SHORT PROGRAM BIO-RAD
K050536 03/02/2005 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL BIO-RAD
K020878 03/18/2002 LYPHOCHEK HEMOSTASIS, MODELS 798, 799 BIO-RAD
K021498 05/09/2002 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL BIO-RAD
K041561 06/10/2004 LIQUICHEK WHOLE BLOOD VOLATILES CONTROL BIO-RAD
K032017 06/30/2003 LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 BIO-RAD
K012513 08/06/2001 LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 BIO-RAD
K012656 08/13/2001 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 BIO-RAD
K012722 08/15/2001 LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 BIO-RAD
K012741 08/16/2001 LIQUICHEK TDM CONTROL BIO-RAD
K032611 08/25/2003 LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 BIO-RAD
K022991 09/09/2002 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 BIO-RAD
K052838 10/07/2005 LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 BIO-RAD
K033366 10/21/2003 LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 BIO-RAD
K033387 10/23/2003 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD
K033404 10/24/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) BIO-RAD
K043208 11/19/2004 LIQUID ASSAYED MULTIQUAL CONTROL BIO-RAD
K042324 08/27/2004 LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 BIO-RAD
K993107 09/17/1999 BIO-RAD HOMOCYSTEINE BY HPLC BIO-RAD
K955116 11/09/1995 BENZODIAZEPINES BY REMEDI HS BIO-RAD
K050537 03/02/2005 LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS BIO-RAD
K052053 07/29/2005 LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK BIO-RAD
K042865 10/18/2004 LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) BIO-RAD
K171061 04/10/2017 MRSASelect II Bio-Rad
K960437 01/31/1996 RADIAS PHENYLALANINE TEST BIO-RAD
K961432 04/15/1996 RADIAS GALT TEST BIO-RAD
K963040 08/05/1996 MANUAL PHENYLALANINE TEST BIO-RAD
K973350 09/05/1997 BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST BIO-RAD
K020610 02/25/2002 LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 BIO-RAD
K011579 05/22/2001 LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 BIO-RAD
K024220 12/23/2002 LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 BIO-RAD
K024219 12/23/2002 LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 BIO-RAD
K024218 12/23/2002 LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 BIO-RAD
K024217 12/23/2002 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 BIO-RAD
K024226 12/23/2002 LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 BIO-RAD
K024232 12/23/2002 LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 BIO-RAD
K024231 12/23/2002 LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 BIO-RAD
K024230 12/23/2002 LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 BIO-RAD
K024229 12/23/2002 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 BIO-RAD
K024227 12/23/2002 LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 BIO-RAD
K024223 12/23/2002 LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 BIO-RAD
K024224 12/23/2002 LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 BIO-RAD
K024222 12/23/2002 LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 BIO-RAD
K024225 12/23/2002 LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 BIO-RAD
K024221 12/23/2002 LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 BIO-RAD


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