MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION— 510(k) K012287

Name: FDA 510(k) clearance K012287
Creator: U.S. Food and Drug Administration
Published: 2001-08-07

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K012287 for MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION, Substantially Equivalent on 2001-08-07. Applicant: Roche Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code MRR
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2001-07-20
Decision date: 2001-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K012287

K-number listed on FDA's recall record

Z-1927-2015 — LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) 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 K012287.

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