Cleared Traditional

GAMMA GLUTAMYLTRANSFERASE REAGENT

K871979 · Intersect Systems, Inc. · Chemistry
Jun 1987
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K871979 is an FDA 510(k) clearance for the GAMMA GLUTAMYLTRANSFERASE REAGENT, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on June 11, 1987, 20 days after receiving the submission on May 22, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K871979 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1987
Decision Date June 11, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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