Bio-Rad

FDA Regulatory Profile

Bio-Rad appears in FDA public data with 0 recalls, 319 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Dec 28, 2017.

Summary

Total Recalls
0
510(k) Clearances
319
Inspections
2
Compliance Actions
0

Known Names

Bio-Rad, Bio-Rad Laboratories (S), Bio-Rad Service France, Biorad

Recent 510(k) Clearances

K-NumberDeviceDate
K171061MRSASelect IIDec 28, 2017
K122187VRESELECT CULTURE MEDIUMNov 6, 2012
K103684VRESELECT CULTURE MEDIUMOct 21, 2011
K093678PLATELIA ASPERGILLUS EIA MODEL 62793Jan 13, 2011
K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSOct 29, 2010
K081362PLATELIA LYME IGMJun 26, 2008
K081212MRSASELECT - EXTENDED INCUBATIONJun 13, 2008
K080012PLATELIA LYME IGG ASSAYMay 8, 2008
K070361MRSASELECTSep 13, 2007
K060641PLATELIA ASPERGILLUS EIA, MODEL 62793Jun 2, 2006
K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4Nov 9, 2005
K052053LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAKAug 9, 2005
K050537LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIACApr 27, 2005
K050536QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROLMar 24, 2005
K043208LIQUID ASSAYED MULTIQUAL CONTROLJan 7, 2005
K042865LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)Nov 24, 2004
K042815QUEST TUMOR MARKER CONTROL, MODEL 955Nov 5, 2004
K042836LIQUICHEK RETICULOCYTE CONTROL (A)Nov 5, 2004
K042837LIQUICHEK ELEVATED CRP CONTROLNov 2, 2004
K042324LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5Oct 7, 2004