Cleared Traditional

LDLC3 LDL-Cholesterol Gen.3

K143691 · Roche Diagnostics Operations (Rdo) · Chemistry
Jan 2015
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K143691 is an FDA 510(k) clearance for the LDLC3 LDL-Cholesterol Gen.3, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on January 28, 2015, 35 days after receiving the submission on December 24, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K143691 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2014
Decision Date January 28, 2015
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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