Cleared Traditional

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT

K133067 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Nov 2013
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K133067 is an FDA 510(k) clearance for the ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on November 22, 2013, 56 days after receiving the submission on September 27, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K133067 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2013
Decision Date November 22, 2013
Days to Decision 56 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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