GAMMA STICK 125-1 TOBRAMYCIN RIA KIT

Radioimmunoassay, Tobramycin

ALPHA GAMMA LABORATORY

The following data is part of a premarket notification filed by Alpha Gamma Laboratory with the FDA for Gamma Stick 125-1 Tobramycin Ria Kit.

Pre-market Notification Details

Device IDK810011
510k NumberK810011
Device Name:GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
ClassificationRadioimmunoassay, Tobramycin
Applicant ALPHA GAMMA LABORATORY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLB  
CFR Regulation Number862.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-05
Decision Date1981-01-28

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