GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY— 510(k) K120199

Name: FDA 510(k) clearance K120199
Creator: U.S. Food and Drug Administration
Published: 2012-10-12

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K120199 for GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY, Substantially Equivalent on 2012-10-12. 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: 2012-01-23
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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