Cleared Traditional

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

K871782 · Biochemical Trade, Inc. · Chemistry
May 1987
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K871782 is an FDA 510(k) clearance for the ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT), a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on May 26, 1987, 20 days after receiving the submission on May 6, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K871782 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1987
Decision Date May 26, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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