Serono-Baker Diagnostics, Inc. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Serono-Baker Diagnostics, Inc. Chemistry ✕
21 devices
Cleared
Nov 30, 1992
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
Chemistry
98d
Cleared
Mar 02, 1992
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
Chemistry
124d
Cleared
Mar 02, 1992
SRI TESTOSTERONE ENZYME IMMUNOASSAY
Chemistry
109d
Cleared
Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
Chemistry
137d
Cleared
Oct 23, 1991
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
Chemistry
16d
Cleared
Sep 18, 1991
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
Chemistry
141d
Cleared
Aug 16, 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
Chemistry
150d
Cleared
Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
Chemistry
62d
Cleared
May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
Chemistry
60d
Cleared
May 24, 1991
SRI TSH IMMUNENZYMETRIC ASSAY
Chemistry
86d
Cleared
May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
Chemistry
69d
Cleared
Jan 23, 1991
SEROZYME CORTISOL TEST KIT
Chemistry
148d