REAGENT, VDRL

Antigens, Ha, Treponema Pallidum

GAMMA BIOLOGICALS, INC.

The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Reagent, Vdrl.

Pre-market Notification Details

Device IDK760098
510k NumberK760098
Device Name:REAGENT, VDRL
ClassificationAntigens, Ha, Treponema Pallidum
Applicant GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMT  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-06-14
Decision Date1976-08-03

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