510(k) K971573— N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

Substantially Equivalent

Genzyme Corp.

Clearance details

Applicant: Genzyme Corp.
Product code: Code LBR
Advisory panel: Clinical Chemistry
Date received: 1997-04-30
Decision date: 1997-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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