BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER— 510(k) K130122

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K130122 for BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER, Substantially Equivalent on 2014-01-07. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CFN
Advisory panel: Immunology
Date received: 2013-01-17
Decision date: 2014-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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