N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR— 510(k) K971190

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K971190 for N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR, Substantially Equivalent on 1997-06-16. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code LBS
Advisory panel: Clinical Chemistry
Date received: 1997-03-31
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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