Cleared Traditional

ALTLTS ALANINE AMINO TRANSFERASE ALT

K883205 · Electro-Nucleonics, Inc. · Chemistry
Sep 1988
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K883205 is an FDA 510(k) clearance for the ALTLTS ALANINE AMINO TRANSFERASE ALT, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 9, 1988, 43 days after receiving the submission on July 28, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K883205 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1988
Decision Date September 09, 1988
Days to Decision 43 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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