Bio-Rad Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System, Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
82
Total
82
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio-Rad Laboratories, Inc. Microbiology ✕
15 devices
Cleared
Mar 26, 2012
BIOPLEX 2200 TORC IGG
Microbiology
28d
Cleared
Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
Microbiology
30d
Cleared
Oct 29, 2009
MONOLISA ANTI-HAV IGM EIA
Microbiology
86d
Cleared
Oct 29, 2009
MONOLISA ANTI-HAV EIA
Microbiology
86d
Cleared
Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
Microbiology
418d
Cleared
Dec 08, 2006
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Microbiology
129d
Cleared
Dec 08, 2006
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Microbiology
129d
Cleared
May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
Microbiology
50d
Cleared
Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
Microbiology
340d
Cleared
Apr 09, 1996
ACCESS RUBELLA IGG
Microbiology
181d
Cleared
Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
Microbiology
264d
Cleared
May 19, 1995
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
Microbiology
533d
Cleared
Sep 20, 1994
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
Microbiology
316d
Cleared
Feb 12, 1993
KALLESTAD RSV MICROPLATE EIA
Microbiology
175d
Cleared
Mar 04, 1992
KALLESTAD ROTAVIRUS MICROPLATE
Microbiology
112d