Medical Device Manufacturer · US , Walker , MI

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

25 submissions · 25 cleared · Since 1984

25

Total

25

Cleared

0

Denied

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

18 devices

1-12 of 18

Cleared Sep 09, 1988

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS

Chemistry · 49d

Cleared Aug 08, 1988

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA

Chemistry · 62d

Cleared Mar 03, 1988

T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE

Chemistry · 35d

Cleared Feb 11, 1988

T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

Chemistry · 76d

Cleared Oct 20, 1987

PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH

Chemistry · 55d

Cleared Sep 29, 1987

LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA

Chemistry · 48d

Cleared Sep 25, 1987

PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA

Chemistry · 32d

Cleared Sep 18, 1987

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS

Chemistry · 59d

Cleared Aug 05, 1987

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE

Chemistry · 28d

Cleared Jul 31, 1987

TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.

Chemistry · 8d

Cleared Jul 21, 1987

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH

Chemistry · 15d

Cleared Jan 07, 1987

TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP

Chemistry · 36d