Cleared Traditional

AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)

K894310 · American Research Products Co. · Chemistry
Sep 1989
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K894310 is an FDA 510(k) clearance for the AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730), a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on September 28, 1989, 76 days after receiving the submission on July 14, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K894310 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1989
Decision Date September 28, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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