Cleared Traditional

TRIGLYCERIDES-E

K863075 · J. D. Assoc. · Chemistry
Sep 1986
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K863075 is an FDA 510(k) clearance for the TRIGLYCERIDES-E, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 26, 1986, 45 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K863075 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date September 26, 1986
Days to Decision 45 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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