SERUM GLUTAMIC-PYRUVIC TRANSAMINASE

Vanillin Pyruvate, Alt/sgpt

GAMMA ENTERPRISES, INC.

The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Serum Glutamic-pyruvic Transaminase.

Pre-market Notification Details

Device IDK780507
510k NumberK780507
Device Name:SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
ClassificationVanillin Pyruvate, Alt/sgpt
Applicant GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCKC  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-30
Decision Date1978-05-03

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