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Bio-Rad

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K171061MRSASelect IIDecember 28, 2017
K122187VRESELECT CULTURE MEDIUMNovember 6, 2012
K103684VRESELECT CULTURE MEDIUMOctober 21, 2011
K093678PLATELIA ASPERGILLUS EIA MODEL 62793January 13, 2011
K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSOctober 29, 2010
K081362PLATELIA LYME IGMJune 26, 2008
K081212MRSASELECT - EXTENDED INCUBATIONJune 13, 2008
K080012PLATELIA LYME IGG ASSAYMay 8, 2008
K070361MRSASELECTSeptember 13, 2007
K060641PLATELIA ASPERGILLUS EIA, MODEL 62793June 2, 2006
K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4November 9, 2005
K052053LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAKAugust 9, 2005
K050537LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIACApril 27, 2005
K050536QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROLMarch 24, 2005
K043208LIQUID ASSAYED MULTIQUAL CONTROLJanuary 7, 2005
K042865LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)November 24, 2004
K042836LIQUICHEK RETICULOCYTE CONTROL (A)November 5, 2004
K042815QUEST TUMOR MARKER CONTROL, MODEL 955November 5, 2004
K042837LIQUICHEK ELEVATED CRP CONTROLNovember 2, 2004
K042324LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5October 7, 2004