Medical Device Manufacturer · US , Mchenry , IL

Clinical Assays, Inc.

27 submissions · 27 cleared · Since 1977
27
Total
27
Cleared
0
Denied

Clinical Assays, Inc. — FDA 510(k) Submissions

Clinical Assays, Inc. has submitted 27 FDA 510(k) premarket notifications since 1977, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Total Thyroxine, Acid, Folic, Radioimmunoassay, Radioassay, Vitamin B12, Radioimmunoassay, Phenobarbital, Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

27 devices
1–12 of 27
VITAMIN B12 RADIOASSAY KIT CA-1534
K832710 · CDD Radioassay, Vitamin B12 · Chemistry
Oct 1983 53d
VITAMIN B12 FOLATE CA-1515-125
K832711 · CDD Radioassay, Vitamin B12 · Chemistry
Oct 1983 53d
FOLATE RADIOASSAY KIT CA-1562-125
K832712 · CGN Acid, Folic,... · Chemistry
Oct 1983 53d
GAMMADAB LH RADIO-KIT #CA-1508
K823476 · CEP Radioimmunoassay,... · Chemistry
Dec 1982 36d
IN VITRO GAMMACOAT B-HCG RADIO. TEST
K823313 · JHI Visual, Pregnancy Hcg,... · Chemistry
Dec 1982 47d
GAMMADAB [125] FSH RADIOIMMUNAY KIT
K821611 · CGJ Radioimmunoassay,... · Chemistry
Jun 1982 22d
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
K821092 · DGC Ige, Antigen, Antiserum,... · Chemistry
Jun 1982 64d
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
K812227 · CFP Radioimmunoassay,... · Chemistry
Sep 1981 45d
GASTRIN RADIOIMMUNOASSAY TEST
K810722 · CGC Radioimmunoassay, Gastrin · Chemistry
May 1981 71d
IN-VITRO TBG RADIOIMMUNOASSAY TEST
K810967 · CEE Radioimmunoassay,... · Chemistry
Apr 1981 15d
GAMMA COAT(125 I) RUBELLA ANTIBODY
K801667 · GOL Antigen, Ha (including Ha... · Microbiology
Oct 1980 94d
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497 · JFH Acid Phosphatase... · Chemistry
Dec 1979 123d
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