Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
16 devices
Cleared
Dec 28, 2017
MRSASelect II
Microbiology
262d
Cleared
Nov 06, 2012
VRESELECT CULTURE MEDIUM
Microbiology
105d
Cleared
Oct 21, 2011
VRESELECT CULTURE MEDIUM
Microbiology
308d
Cleared
Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
Microbiology
412d
Cleared
Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
Microbiology
241d
Cleared
Jun 26, 2008
PLATELIA LYME IGM
Microbiology
42d
Cleared
Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
Microbiology
45d
Cleared
May 08, 2008
PLATELIA LYME IGG ASSAY
Microbiology
126d
Cleared
Sep 13, 2007
MRSASELECT
Microbiology
218d
Cleared
Jun 02, 2006
PLATELIA ASPERGILLUS EIA, MODEL 62793
Microbiology
84d
Cleared
May 16, 2003
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
Microbiology
177d
Cleared
Sep 30, 2002
BIO-RAD PLATELIA TOXO IGM TMB
Microbiology
315d
Cleared
Sep 30, 2002
BIO-RAD PLATELIA TOXO IGG TMB
Microbiology
315d
Cleared
Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
Microbiology
20d
Cleared
May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
Microbiology
16d
Cleared
May 22, 1979
QUANTAZYME TOXOPLASMA
Microbiology
89d