Cleared Traditional

ECLIPSE ICA TRIGLYCERIDES

K905601 · Biotope, Inc. · Chemistry
Jan 1991
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K905601 is an FDA 510(k) clearance for the ECLIPSE ICA TRIGLYCERIDES, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on January 17, 1991, 35 days after receiving the submission on December 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K905601 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1990
Decision Date January 17, 1991
Days to Decision 35 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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