Cleared Traditional

TRIGLYCERIDES, TG, OR TRIG

K971324 · Carolina Liquid Chemistries Corp. · Chemistry
Jun 1997
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K971324 is an FDA 510(k) clearance for the TRIGLYCERIDES, TG, OR TRIG, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 20, 1997, 71 days after receiving the submission on April 10, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K971324 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1997
Decision Date June 20, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1705

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