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510(k) K955449

ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY by American Laboratory Products Co., Ltd. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1996
Date Received
November 29, 1995
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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