Cleared Traditional

HDL-Cholesterol Gen.4

K162593 · Roche Diagnostics Operations (Rdo) · Chemistry

Oct 2016

Decision

33d

Days

Class 1

Risk

About This 510(k) Submission

K162593 is an FDA 510(k) clearance for the HDL-Cholesterol Gen.4, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on October 19, 2016, 33 days after receiving the submission on September 16, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K162593 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2016
Decision Date	October 19, 2016
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1475