Cleared Traditional

GGT REAGENT

K905618 · Amresco, Inc. · Chemistry
Feb 1991
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K905618 is an FDA 510(k) clearance for the GGT REAGENT, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on February 26, 1991, 74 days after receiving the submission on December 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K905618 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1990
Decision Date February 26, 1991
Days to Decision 74 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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