Cleared Traditional

VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR

K034000 · Clinical Data, Inc. · Chemistry
Mar 2004
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K034000 is an FDA 510(k) clearance for the VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 10, 2004, 77 days after receiving the submission on December 24, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K034000 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2003
Decision Date March 10, 2004
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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