Bio-Rad Laboratories - FDA 510(k) Cleared Devices
Recent clearances: BioPlex 2200 Lyme Total, BioPlex 2200 25-OH Vitamin D Kit, BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
46
Total
45
Cleared
1
Denied
FDA 510(k) Regulatory Record - Bio-Rad Laboratories Microbiology ✕
15 devices
Cleared
Mar 12, 2019
BioPlex 2200 Lyme Total
Microbiology
90d
Cleared
May 19, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200...
Microbiology
87d
Cleared
May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...
Microbiology
90d
Cleared
May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek...
Microbiology
235d
Not Cleared
Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...
Microbiology
103d
Cleared
Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
Microbiology
36d
Cleared
Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
Microbiology
84d
Cleared
Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
Microbiology
127d
Cleared
Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...
Microbiology
466d
Cleared
Mar 29, 2010
BIOPLEX 2200 MMRV IGG
Microbiology
299d
Cleared
Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
Microbiology
93d
Cleared
May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...
Microbiology
79d