ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)

Nadh Oxidation/nad Reduction, Alt/sgpt

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Ultraviolet Alanine Amino-trans (uv-alt/uv-gpt).

Pre-market Notification Details

Device IDK871782
510k NumberK871782
Device Name:ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
ContactRoy, Ph.d.
CorrespondentRoy, Ph.d.
BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-06
Decision Date1987-05-26

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