HDL CHOLESTEROL REAGENT— 510(k) K911406

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K911406 for HDL CHOLESTEROL REAGENT, Substantially Equivalent on 1991-05-22. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code LBR
Advisory panel: Clinical Chemistry
Date received: 1991-03-29
Decision date: 1991-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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