COBAS INTEGRA CHOLESTEROL GEN. 2— 510(k) K031824

Name: FDA 510(k) clearance K031824
Creator: U.S. Food and Drug Administration
Published: 2003-07-09

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K031824 for COBAS INTEGRA CHOLESTEROL GEN. 2, Substantially Equivalent on 2003-07-09. Applicant: Roche Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2003-06-13
Decision date: 2003-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K031824

K-number listed on FDA's recall record

Z-1921-2015 — Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol 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 K031824.

Data sourced from openFDA. This site is unofficial and independent of the FDA.