SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT— 510(k) K010748

Name: FDA 510(k) clearance K010748
Creator: U.S. Food and Drug Administration
Published: 2001-07-10

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K010748 for SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT, Substantially Equivalent on 2001-07-10. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2001-03-13
Decision date: 2001-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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