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510(k) K023433

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

K023433 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics GmbH & Co. KG for the device "VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896". The FDA issued a decision of Substantially Equivalent on November 13, 2002. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660.

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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FDA data resources