DRI-STAT ACID PHOSPHATASE REAGENT— 510(k) K053612

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K053612 for DRI-STAT ACID PHOSPHATASE REAGENT, Substantially Equivalent on 2006-04-26. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CKB
Advisory panel: Clinical Chemistry
Date received: 2005-12-27
Decision date: 2006-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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