ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647— 510(k) K072612

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K072612 for ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647, Substantially Equivalent on 2007-10-26. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2007-09-17
Decision date: 2007-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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