K072612

Substantially Equivalent

ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647

Applicant: Beckman Coulter, Inc.
Product 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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