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Serono-Baker Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYNovember 30, 1992
K914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)March 2, 1992
K915164SRI TESTOSTERONE ENZYME IMMUNOASSAYMarch 2, 1992
K915602SRI DIGOXIN ENZYME IMMUNOASSAYJanuary 17, 1992
K912937SR1 FREE T4 ENZYME IMMUNOASSAYNovember 19, 1991
K914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)October 23, 1991
K911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)September 18, 1991
K911217SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)August 16, 1991
K912318ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)July 25, 1991
K911396SR1 ESTRADIOL ENZYME IMMUNOASSAYMay 28, 1991
K910837SRI TSH IMMUNENZYMETRIC ASSAYMay 24, 1991
K910737SRI T3 IMMOENZYMETRIC ASSAYMay 1, 1991
K911175SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)April 5, 1991
K903975SEROZYME CORTISOL TEST KITJanuary 23, 1991
K896145ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAYDecember 27, 1989
K894175SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAYDecember 19, 1989
K895380SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAYOctober 17, 1989
K893605SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAYJune 20, 1989
K892706SR1 (FSH) IMMUNOENZYMETRIC ASSAYJune 9, 1989
K890645ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KITMarch 8, 1989