MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION— 510(k) K012286

Clearance details

Applicant

Roche Diagnostics Corp.

Product code

Code LBS

Device class

Class 1

Regulation

21 CFR 862.1475

Advisory panel

Clinical Chemistry

Date received

2001-07-20

Decision date

2001-08-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Indianapolis, IN, US

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• Z-1925-2015 — HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.Class II·Terminated·Roche Diagnostics Operations, Inc.·20150507

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012286.