BOEHRINGER MANNHEIM CHOLESTEROL ASSAY— 510(k) K952127

Name: FDA 510(k) clearance K952127
Creator: U.S. Food and Drug Administration
Published: 1995-07-20

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K952127 for BOEHRINGER MANNHEIM CHOLESTEROL ASSAY, Substantially Equivalent on 1995-07-20. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1995-05-08
Decision date: 1995-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K952127

K-number listed on FDA's recall record

Z-1920-2015 — Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi 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 K952127.

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