MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS— 510(k) K033674

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K033674 for MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS, Substantially Equivalent on 2004-02-09. Applicant: Seradyn, Inc..

Clearance details

Applicant: Seradyn, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2003-11-24
Decision date: 2004-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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