DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT— 510(k) K924674

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K924674 for DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT, Substantially Equivalent on 1993-01-06. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1992-09-16
Decision date: 1993-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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