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510(k) K030741

AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA by Hycor Biomedical , Ltd. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2003
Date Received
March 10, 2003
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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