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

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..

Clearance details

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

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