GENTIAN CYSTATIN C IMMUNOASSAY— 510(k) K081875

Substantially Equivalent

Gentian AS

FDA 510(k) clearance K081875 for GENTIAN CYSTATIN C IMMUNOASSAY, Substantially Equivalent on 2008-08-20. Applicant: Gentian AS.

Clearance details

Applicant: Gentian AS
Product code: Code NDY
Advisory panel: Clinical Chemistry
Date received: 2008-07-02
Decision date: 2008-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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