GAMMA STICK CORTISOL RIA KIT/STICK KIT

Radioimmunoassay, Cortisol

ALPHA GAMMA LABORATORY

The following data is part of a premarket notification filed by Alpha Gamma Laboratory with the FDA for Gamma Stick Cortisol Ria Kit/stick Kit.

Pre-market Notification Details

Device IDK800538
510k NumberK800538
Device Name:GAMMA STICK CORTISOL RIA KIT/STICK KIT
ClassificationRadioimmunoassay, Cortisol
Applicant ALPHA GAMMA LABORATORY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-10
Decision Date1980-04-24

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