Cleared Traditional

TRIGLYCERIDES REAGENT SYSTEM

K843832 · Fermco Biochemics, Inc. · Chemistry
Nov 1984
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K843832 is an FDA 510(k) clearance for the TRIGLYCERIDES REAGENT SYSTEM, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Fermco Biochemics, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on November 27, 1984, 57 days after receiving the submission on October 1, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K843832 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1984
Decision Date November 27, 1984
Days to Decision 57 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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