Cleared Traditional

GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET

K860110 · Technostics Intl. · Chemistry
Feb 1986
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K860110 is an FDA 510(k) clearance for the GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on February 11, 1986, 29 days after receiving the submission on January 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K860110 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1986
Decision Date February 11, 1986
Days to Decision 29 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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