Cleared Traditional

TRIGLYCERIDES DETERMINATION

K871122 · Biochemical Trade, Inc. · Chemistry
Apr 1987
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K871122 is an FDA 510(k) clearance for the TRIGLYCERIDES DETERMINATION, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on April 7, 1987, 18 days after receiving the submission on March 20, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K871122 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1987
Decision Date April 07, 1987
Days to Decision 18 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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