DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

System, Test, Infectious Mononucleosis

GAMMA BIOLOGICALS, INC.

The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Disposable Test Cards/gamma Slide Test Infect Mono.

Pre-market Notification Details

Device IDK864207
510k NumberK864207
Device Name:DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
ClassificationSystem, Test, Infectious Mononucleosis
Applicant GAMMA BIOLOGICALS, INC. 3700 MANGUM RD., #451-M Houston,  TX  77092 -5497
ContactJohn Case
CorrespondentJohn Case
GAMMA BIOLOGICALS, INC. 3700 MANGUM RD., #451-M Houston,  TX  77092 -5497
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-27
Decision Date1986-12-03

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