GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR— 510(k) K080662

Name: FDA 510(k) clearance K080662
Creator: U.S. Food and Drug Administration
Published: 2008-05-15

Substantially Equivalent

Genzyme Corporation

FDA 510(k) clearance K080662 for GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR, Substantially Equivalent on 2008-05-15. Applicant: Genzyme Corporation. Device class: 2.

Clearance details

Applicant: Genzyme Corporation
Product code: Code NDY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2008-03-10
Decision date: 2008-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

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