Serono-Baker Diagnostics, Inc.

FDA Regulatory Profile

Serono-Baker Diagnostics, Inc. appears in FDA public data with 0 recalls, 23 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Nov 30, 1992.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYNov 30, 1992
K915164SRI TESTOSTERONE ENZYME IMMUNOASSAYMar 2, 1992
K914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)Mar 2, 1992
K915602SRI DIGOXIN ENZYME IMMUNOASSAYJan 17, 1992
K912937SR1 FREE T4 ENZYME IMMUNOASSAYNov 19, 1991
K914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)Oct 23, 1991
K911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)Sep 18, 1991
K911217SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)Aug 16, 1991
K912318ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)Jul 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)Apr 5, 1991
K903975SEROZYME CORTISOL TEST KITJan 23, 1991
K896145ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAYDec 27, 1989
K894175SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAYDec 19, 1989
K895380SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAYOct 17, 1989
K893605SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAYJun 20, 1989
K892706SR1 (FSH) IMMUNOENZYMETRIC ASSAYJun 9, 1989
K890645ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KITMar 8, 1989