Medical Device Manufacturer · US , Winchester , VA

Serono-Baker Diagnostics, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1988
23
Total
23
Cleared
0
Denied

Serono-Baker Diagnostics, Inc. has 23 FDA 510(k) cleared chemistry devices. Based in Winchester, US.

Historical record: 23 cleared submissions from 1988 to 1992.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Serono-Baker Diagnostics, Inc.

23 devices
1-23 of 23
Cleared Nov 30, 1992
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
K924257 · CDZ
Chemistry · 98d
Cleared Mar 02, 1992
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
K914886 · CGR
Chemistry · 124d
Cleared Mar 02, 1992
SRI TESTOSTERONE ENZYME IMMUNOASSAY
K915164 · CDZ
Chemistry · 109d
Cleared Jan 17, 1992
SRI DIGOXIN ENZYME IMMUNOASSAY
K915602 · KXT
Toxicology · 35d
Cleared Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937 · CEC
Chemistry · 137d
Cleared Oct 23, 1991
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
K914462 · JLS
Chemistry · 16d
Cleared Sep 18, 1991
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
K911912 · KHQ
Chemistry · 141d
Cleared Aug 16, 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
K911217 · KLI
Chemistry · 150d
Cleared Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
K912318 · CHP
Chemistry · 62d
Cleared May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
K911396 · CHP
Chemistry · 60d
Cleared May 24, 1991
SRI TSH IMMUNENZYMETRIC ASSAY
K910837 · JLW
Chemistry · 86d
Cleared May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
K910737 · CDP
Chemistry · 69d
Cleared Apr 05, 1991
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · DBF
Immunology · 18d
Cleared Jan 23, 1991
SEROZYME CORTISOL TEST KIT
K903975 · CGR
Chemistry · 148d
Cleared Dec 27, 1989
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
K896145 · CHP
Chemistry · 65d
Cleared Dec 19, 1989
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
K894175 · JHI
Chemistry · 187d
Cleared Oct 17, 1989
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
K895380 · CFT
Chemistry · 48d
Cleared Jun 20, 1989
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
K893605 · CEP
Chemistry · 41d
Cleared Jun 09, 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
K892706 · CGJ
Chemistry · 56d
Cleared Mar 08, 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645 · CHP
Chemistry · 28d
Cleared Feb 02, 1989
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY
K884794 · JLS
Chemistry · 78d
Cleared Dec 27, 1988
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
K884683 · DBF
Chemistry · 49d
Cleared Oct 31, 1988
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
K883539 · JJE
Chemistry · 76d
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