DeviceClearance

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

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.

Clearance details

Applicant
Genzyme Corporation
Product code
Code NDY
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Framingham, MA, US
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