Serono Diagnostics, Inc. is one of 13457 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Serono Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS, SR1 DHEA-S ENZYME IMMUNOASSAY, T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
25
Total
25
Cleared
0
Denied
Serono Diagnostics, Inc. has 25 FDA 510(k) cleared chemistry devices. Based in Walker, US.
Historical record: 25 cleared submissions from 1984 to 1996.
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 Diagnostics, Inc.
25 devices
Cleared
Mar 11, 1996
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
Hematology
223d
Cleared
Jul 13, 1994
SR1 DHEA-S ENZYME IMMUNOASSAY
Toxicology
76d
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
Sep 14, 1987
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
Immunology
41d
Cleared
Aug 05, 1987
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
Chemistry
28d