Cleared Traditional

TRIGLYCERIDES

K971005 · Derma Media Lab., Inc. · Chemistry
Apr 1997
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K971005 is an FDA 510(k) clearance for the TRIGLYCERIDES, a Colorimetric Method, Triglycerides (Class I — General Controls, product code JGY), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 21, 1997, 33 days after receiving the submission on March 19, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K971005 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1997
Decision Date April 21, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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