Cleared Traditional

K851999 - G-GT REAGENT
(FDA 510(k) Clearance)

K851999 · Alpkem Corp. · Chemistry
Jun 1985
Decision
34d
Days
Class 1
Risk

K851999 is an FDA 510(k) clearance for the G-GT REAGENT, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 10, 1985, 34 days after receiving the submission on May 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K851999 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date June 10, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQB — Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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