Cleared Traditional

DNA TRIGLYCERIDE PROCEDURE

K941063 · Data Medical Associates, Inc. · Chemistry
Jul 1994
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K941063 is an FDA 510(k) clearance for the DNA TRIGLYCERIDE PROCEDURE, a Colorimetric Method, Triglycerides (Class I — General Controls, product code JGY), submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on July 20, 1994, 134 days after receiving the submission on March 8, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K941063 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1994
Decision Date July 20, 1994
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGY — Colorimetric Method, Triglycerides
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1705

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