BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL— 510(k) K970735

Name: FDA 510(k) clearance K970735
Creator: U.S. Food and Drug Administration
Published: 1997-06-06

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K970735 for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL, Substantially Equivalent on 1997-06-06. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1997-02-18
Decision date: 1997-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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