N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET— 510(k) K992766

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K992766 for N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET, Substantially Equivalent on 1999-10-18. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1999-08-17
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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