ALT(GPT) UNI-UV, SGPT

Nadh Oxidation/nad Reduction, Alt/sgpt

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Alt(gpt) Uni-uv, Sgpt.

Pre-market Notification Details

Device IDK780462
510k NumberK780462
Device Name:ALT(GPT) UNI-UV, SGPT
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-23
Decision Date1978-05-12

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