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

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.

25 devices
1–12 of 25
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
K953598 · GKZ Counter, Differential Cell · Hematology
Mar 1996 223d
SR1 DHEA-S ENZYME IMMUNOASSAY
K942051 · JKC Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) · Toxicology
Jul 1994 76d
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
K883085 · KHQ Radioassay, Triiodothyronine Uptake · Chemistry
Sep 1988 49d
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K882340 · CEP Radioimmunoassay, Luteinizing Hormone · Chemistry
Aug 1988 62d
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
K880388 · CDP Radioimmunoassay, Total Triiodothyronine · Chemistry
Mar 1988 35d
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866 · KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · Chemistry
Feb 1988 76d
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
K873431 · JLS Radioimmunoassay, Progesterone · Chemistry
Oct 1987 55d
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186 · CEP Radioimmunoassay, Luteinizing Hormone · Chemistry
Sep 1987 48d
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400 · CFT Radioimmunoassay, Prolactin (lactogen) · Chemistry
Sep 1987 32d
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
K872862 · CFT Radioimmunoassay, Prolactin (lactogen) · Chemistry
Sep 1987 59d
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
K873033 · JHI Visual, Pregnancy Hcg, Prescription Use · Immunology
Sep 1987 41d
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K872727 · CEP Radioimmunoassay, Luteinizing Hormone · Chemistry
Aug 1987 28d
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