Cleared Traditional

TRIGLYCERIDES

K931891 · Em Diagnostic Systems, Inc. · Chemistry
Aug 1993
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K931891 is an FDA 510(k) clearance for the TRIGLYCERIDES, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 25, 1993, 132 days after receiving the submission on April 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K931891 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1993
Decision Date August 25, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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