Medical Device Manufacturer · US , Mchenry , IL

Alpha Gamma Laboratory

4 submissions · 4 cleared · Since 1978

Total

Cleared

Denied

Alpha Gamma Laboratory — FDA 510(k) Submissions

Alpha Gamma Laboratory has submitted 4 FDA 510(k) premarket notifications since 1978, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Total Triiodothyronine, Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep., Radioimmunoassay, Cortisol, Radioimmunoassay, Tobramycin . Use the specialty filter in the sidebar to narrow results.

4 devices

1–4 of 4

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT

K810011 · KLB Radioimmunoassay, Tobramycin · Toxicology

Jan 1981 23d

GAMMA STICK GENTAMICIN RIA KIT

K800537 · DJB Radioimmunoassay,... · Toxicology

Apr 1980 45d

GAMMA STICK CORTISOL RIA KIT/STICK KIT

K800538 · CGR Radioimmunoassay, Cortisol · Chemistry

Apr 1980 45d

GAMMA STIK 125I T3 UPTAKE KIT

K780492 · CDP Radioimmunoassay, Total... · Chemistry

Apr 1978 32d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Alpha Gamma Laboratory

Alpha Gamma Laboratory — FDA 510(k) Submissions

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