Serono Diagnostics, Inc. - FDA 510(k) Cleared Devices
25
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Serono Diagnostics, Inc. Chemistry ✕
18 devices
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
Cleared
Sep 16, 1986
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
Chemistry
54d
Cleared
Jul 29, 1986
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
Chemistry
46d
Cleared
Jun 27, 1986
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
Chemistry
78d
Cleared
Oct 11, 1984
GASTRIN RADIOIMMUNOASSAY TEST KIT
Chemistry
76d
Cleared
Oct 11, 1984
RENIN RADIOIMMUNOASSAY TEST KIT
Chemistry
76d
Cleared
Apr 13, 1984
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
Chemistry
196d