SYSTEM CALIBRATER— 510(k) K141388

Substantially Equivalent

Beckman Coulter Ireland, Inc.

FDA 510(k) clearance K141388 for SYSTEM CALIBRATER, Substantially Equivalent on 2014-07-11. Applicant: Beckman Coulter Ireland, Inc..

Clearance details

Applicant: Beckman Coulter Ireland, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2014-05-27
Decision date: 2014-07-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Brea, CA, US

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