510(k) K033036— BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647

Substantially Equivalent

Beckman Coulter, Inc.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2003-09-29
Decision date: 2004-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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