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510(k) K033036

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 by Beckman Coulter, Inc. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2004
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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