Medical Device Manufacturer · US , Mchenry , IL

Clinical Assays, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1977

27

Total

27

Cleared

0

Denied

FDA 510(k) Regulatory Record - Clinical Assays, Inc. Chemistry ✕

15 devices

1-12 of 15

Cleared Oct 04, 1983

VITAMIN B12 RADIOASSAY KIT CA-1534

Chemistry · 53d

Cleared Oct 04, 1983

VITAMIN B12 FOLATE CA-1515-125

Chemistry · 53d

Cleared Oct 04, 1983

FOLATE RADIOASSAY KIT CA-1562-125

Chemistry · 53d

Cleared Dec 28, 1982

GAMMADAB LH RADIO-KIT #CA-1508

Chemistry · 36d

Cleared Dec 22, 1982

IN VITRO GAMMACOAT B-HCG RADIO. TEST

Chemistry · 47d

Cleared Jun 24, 1982

GAMMADAB [125] FSH RADIOIMMUNAY KIT

Chemistry · 22d

Cleared Jun 22, 1982

GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

Chemistry · 64d

Cleared Sep 24, 1981

GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY

Chemistry · 45d

Cleared May 27, 1981

GASTRIN RADIOIMMUNOASSAY TEST

Chemistry · 71d

Cleared Apr 23, 1981

IN-VITRO TBG RADIOIMMUNOASSAY TEST

Chemistry · 15d

Cleared Dec 04, 1979

PROSTATIC ACID RADIOIMMUNOASSAY TEST

Chemistry · 123d

Cleared Jul 17, 1979

GAMMADAB (125 1) FOLATE RADIOASSAY KIT

Chemistry · 35d