HDL CHOLESTEROL PLUS— 510(k) K000568

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K000568 for HDL CHOLESTEROL PLUS, Substantially Equivalent on 2000-08-04. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LBT
Advisory panel: Clinical Chemistry
Date received: 2000-02-22
Decision date: 2000-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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