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Beckman-Diagnostic Systems Group

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSDecember 12, 1994
K944604CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMSDecember 7, 1994
K944605CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMDecember 7, 1994
K944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSNovember 30, 1994
K942676SYNCHRON CX3 DELTANovember 2, 1994
K934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENTJuly 6, 1994
K934068BECKMAN DIRECT BILIRUBIN REAGENTApril 26, 1994
K936184VIGIL PRX CHEMISTRY CONTROLApril 15, 1994
K934271BECKMAN SYNCHRON LACTATE REAGENTNovember 9, 1993
K934046BECKMAN CHOLESTEROL REAGENTOctober 28, 1993
K934467BECKMAN CX AMMONIA/ALCOHOL CONTROLOctober 27, 1993