BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL— 510(k) K963213

Name: FDA 510(k) clearance K963213
Creator: U.S. Food and Drug Administration
Published: 1996-10-23

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K963213 for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL, Substantially Equivalent on 1996-10-23. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1996-08-16
Decision date: 1996-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K963213

K-number listed on FDA's recall record

Z-1924-2015 — HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-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 K963213.

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