ACCESS EPO ASSAY— 510(k) K052223

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K052223 for ACCESS EPO ASSAY, Substantially Equivalent on 2006-10-06. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GGT
Advisory panel: Hematology
Date received: 2005-08-15
Decision date: 2006-10-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chaska, MN, US

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