Cleared Traditional

VANTERA CLINICAL ANALYZER

K113830 · Liposcience · Chemistry
Aug 2012
Decision
247d
Days
Class 1
Risk

About This 510(k) Submission

K113830 is an FDA 510(k) clearance for the VANTERA CLINICAL ANALYZER, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Liposcience (Raleigh, US). The FDA issued a Cleared decision on August 30, 2012, 247 days after receiving the submission on December 27, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K113830 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2011
Decision Date August 30, 2012
Days to Decision 247 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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