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

Name: FDA 510(k) clearance K033674
Creator: U.S. Food and Drug Administration
Published: 2004-02-09

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.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2003-11-24
Decision date: 2004-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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