UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT— 510(k) K121492

Name: FDA 510(k) clearance K121492
Creator: U.S. Food and Drug Administration
Published: 2012-09-11

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K121492 for UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT, Substantially Equivalent on 2012-09-11. 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: 2012-05-21
Decision date: 2012-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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