Bio-Rad Laboratories, Inc. - FDA 510(k) Cleared Devices
82
Total
82
Cleared
0
Denied
82 devices
Cleared
Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
Immunology
185d
Cleared
Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
Immunology
28d
Cleared
Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
Chemistry
54d
Cleared
Oct 14, 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
Hematology
45d
Cleared
Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
Immunology
18d
Cleared
Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
Chemistry
8d
Cleared
May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
Microbiology
50d
Cleared
Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
Chemistry
13d
Cleared
Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
Chemistry
34d
Cleared
Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
Chemistry
28d
Cleared
Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
Chemistry
47d
Cleared
Aug 27, 2003
D-10 HEMOGLOBIN A1C
Chemistry
148d
Cleared
Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
Immunology
22d
Cleared
Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
Chemistry
30d
Cleared
Feb 25, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
Chemistry
42d
Cleared
Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
Microbiology
340d
Cleared
Dec 16, 1996
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS:...
Chemistry
76d
Cleared
Apr 09, 1996
ACCESS RUBELLA IGG
Microbiology
181d
Cleared
Mar 29, 1996
ACCESS FREE T3 ASSAY
Chemistry
23d
Cleared
Feb 05, 1996
ACCESS PROGESTERONE ASSAY
Chemistry
46d
Cleared
Jan 24, 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
Chemistry
114d
Cleared
Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
Chemistry
114d
Cleared
Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
Microbiology
264d
Cleared
Dec 05, 1995
ACCESS CORTISOL ASSAY (MODIFICATION)
Chemistry
64d
Cleared
Nov 21, 1995
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Chemistry
32d
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