Cleared Traditional

INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT

K870827 · Intersect Systems, Inc. · Chemistry
Mar 1987
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K870827 is an FDA 510(k) clearance for the INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on March 13, 1987, 10 days after receiving the submission on March 3, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K870827 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1987
Decision Date March 13, 1987
Days to Decision 10 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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