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J.T. Baker Chemical Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
54
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K803128SERIES 810 PLATELET ANALYZERApril 3, 1981
K802080BAKER DIAG. ULTRARATE CHLORIDE KITOctober 10, 1980
K801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICSeptember 26, 1980
K802035BAKER DIAG. ULTRARATE CO2 REAGENT KITSeptember 26, 1980
K801662J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.September 16, 1980
K801669J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELOSeptember 16, 1980
K801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.September 16, 1980
K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICSeptember 16, 1980
K801362ALBUMIN NEPHELOMETRIC ASSAYJuly 21, 1980
K801434J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASSJuly 8, 1980
K801432HEMOPEXIN NEPHELOMETRIC ASSAYJuly 8, 1980
K801433HAPTOGLOBIN NEPHELOMETRIC ASSAYJuly 8, 1980
K801361COMPLEMENT C4 NEPHELOMETRIC ASSAYJune 30, 1980
K801283J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAYJune 30, 1980
K801363COMPLEMENT C3 NEPHELOMETRIC ASSAYJune 30, 1980
K801282J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSAJune 30, 1980
K801281J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRIJune 20, 1980
K801090J.T. BAKER LSA 290 PIPETTER/DILUTERJune 9, 1980
K801091K 750 COMPUTER/DATA PROCESSORJune 9, 1980
K801089J.T. BAKER NEPHELOMETERMay 28, 1980