FDA 510(k) Applications Submitted by ELIZABETH PLATT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| 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 |
| 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 |
| 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 |
| K040273 |
02/05/2004 |
LYPHOCHEK ASSAYED CHEMISTRY CONTROL |
BIO-RAD LABORATORIES, INC. |
| K040275 |
02/05/2004 |
LYPHOCHEK HEMOSTASIS CONTROL |
BIO-RAD |
| K150300 |
02/06/2015 |
Liquichek Cardiac Markers Plus Control LT |
Bio-Rad Laboratories |
| 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 |
| K120504 |
02/21/2012 |
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK |
BIO-RAD LABORATORIES, INC. |
| 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 |
| K990608 |
02/24/1999 |
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 |
BIO-RAD |
| K990610 |
02/24/1999 |
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 |
BIO-RAD |
| K070546 |
02/26/2007 |
LYPHOCHEK DIABETES CONTROL |
Bio-Rad Laboratories |
| 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 |
| K020817 |
03/13/2002 |
LIQUICHEK URINE CHEMISTRY CONTROL |
BIO-RAD LABORATORIES, INC. |
| K990858 |
03/15/1999 |
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 |
BIO-RAD |
| K050682 |
03/16/2005 |
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) |
BIO-RAD LABORATORIES, INC. |
| 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 |
| K070848 |
03/28/2007 |
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X |
BIO-RAD, DIAGNOSTICS GRP. |
| 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 |
| K082036 |
07/17/2008 |
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK |
Bio-Rad Laboratories |
| 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 |
| K002536 |
08/16/2000 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) |
BIO-RAD |
| K002535 |
08/16/2000 |
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 |
BIO-RAD |
| K992781 |
08/19/1999 |
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 |
BIO-RAD |
| K002865 |
09/13/2000 |
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 |
BIO-RAD |
| K002866 |
09/13/2000 |
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 |
BIO-RAD |
| K152679 |
09/18/2015 |
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak |
BIO-RAD LABORATORIES |
| K072721 |
09/26/2007 |
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC |
BIO-RAD, DIAGNOSTICS GRP. |
| 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 |
| K042837 |
10/14/2004 |
LIQUICHEK ELEVATED CRP CONTROL |
BIO-RAD |
| K042836 |
10/14/2004 |
LIQUICHEK RETICULOCYTE CONTROL (A) |
BIO-RAD |
| K003239 |
10/17/2000 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 |
BIO-RAD |
| K003242 |
10/17/2000 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 |
BIO-RAD |
| K983807 |
10/28/1998 |
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 |
BIO-RAD |
| K163015 |
10/28/2016 |
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak |
BIO-RAD LABORATORIES |
| K984072 |
11/16/1998 |
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 |
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 |
| K984070 |
11/16/1998 |
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 |
BIO-RAD |
| K984071 |
11/16/1998 |
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 |
BIO-RAD |
| K093577 |
11/18/2009 |
LIQUICHEK OPIATE CONTROL |
Bio-Rad Laboratories |
| K984225 |
11/25/1998 |
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 |
BIO-RAD |
| K143379 |
11/25/2014 |
Liquichek Maternal Serum II Control |
Bio-Rad Laboratories |
| 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 |
| K984323 |
12/03/1998 |
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 |
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 |
| K984400 |
12/09/1998 |
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 |
BIO-RAD |
| K984399 |
12/09/1998 |
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 |
BIO-RAD |
| K984398 |
12/09/1998 |
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 |
BIO-RAD |
| K984397 |
12/09/1998 |
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 |
BIO-RAD |
| K984396 |
12/09/1998 |
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 |
BIO-RAD |
| K964963 |
12/11/1996 |
LYPHOCHEK COAGULATION CONTROL |
BIO-RAD |
| K984479 |
12/16/1998 |
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 |
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 |
| K984475 |
12/16/1998 |
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 |
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 |
| K984462 |
12/16/1998 |
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 |
BIO-RAD |
| K984473 |
12/16/1998 |
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 |
BIO-RAD |
| K984478 |
12/16/1998 |
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 |
BIO-RAD |
| DEN150058 |
12/16/2015 |
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak |
Bio-Rad Laboratories |
| K033924 |
12/18/2003 |
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) |
BIO-RAD LABORATORIES, INC. |
| K965171 |
12/24/1996 |
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) |
BIO-RAD |
| K984626 |
12/28/1998 |
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 |
BIO-RAD |
| K984594 |
12/28/1998 |
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 |
BIO-RAD |
| K984604 |
12/28/1998 |
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 |
BIO-RAD |
| K984625 |
12/28/1998 |
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 |
BIO-RAD |
|
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