Sigma Chemical Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
231
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K933694SIGMA GLUCOSE REAGENTNovember 4, 1994
K933678SIGMA CALCIUM REAGENTMarch 11, 1994
K933696SIGMA ELECTROLYTE REFERENCE REAGENTJanuary 3, 1994
K933691SIGMA CO2 ALKALINE BUFFER REAGENTDecember 17, 1993
K933679SIGMA BUN REAGENTDecember 17, 1993
K933703SIGMA WASH CONCENTRATE SOLUTIONDecember 10, 1993
K933692SIGMA CO2 ACID REAGENTDecember 9, 1993
K933695SIGMA ELECTROLYTE BUFFEROctober 22, 1993
K933697SIGMA CRE REAGENTOctober 18, 1993
K933693SIGMA CX-3 CALIBRATION STANDARD LEVEL 2October 13, 1993
K933702SIGMA CX-3 CALIBRATION STANDARD LEVEL 1October 8, 1993
K930050SIA THYROID STIMULATING HORMONE ELISA KITAugust 19, 1993
K901186MONOCLONAL ANTIBODY ANTI-CD19October 31, 1991
K901187MONOCLONAL ANTIBODY ANTI-CD2October 31, 1991
K901189MONOCLONAL ANTIBODY ANTI-CD3October 31, 1991
K901188MONOCLONAL ANTIBODY ANTI-CD5October 31, 1991
K904022NITRO BLUE TETRAZOLIUM REDUCTIONDecember 18, 1990
K903995NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITDecember 13, 1990
K904341APTT REAGENTNovember 8, 1990
K902098CHOLESTEROL (RATE) REAGENTAugust 9, 1990