Cleared Traditional

GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST

K935177 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K935177 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993, 51 days after receiving the submission on October 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K935177 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date December 16, 1993
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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