Cleared Traditional

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE

K961919 · Data Medical Associates, Inc. · Chemistry
Jul 1996
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K961919 is an FDA 510(k) clearance for the DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on July 1, 1996, 45 days after receiving the submission on May 17, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K961919 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1996
Decision Date July 01, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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