RST-SERIES CONTROL

Kit, Quality Control For Blood Banking Reagents

GAMMA BIOLOGICALS, INC.

The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Rst-series Control.

Pre-market Notification Details

Device IDK800658
510k NumberK800658
Device Name:RST-SERIES CONTROL
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-26
Decision Date1980-04-16

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