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510(k) K023433

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 by Pharmacia Diagnostics GmbH & Co. KG — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2002
Date Received
October 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Anticardiolipin Immunological
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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