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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K952523
Device Name CARDIOLIPIN IGG EIA TEST KIT
Applicant
Immunoprobe, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact EDWARD C WILSON, JR.
Correspondent
Immunoprobe, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact EDWARD C WILSON, JR.
Regulation Number866.5660
Classification Product Code
MID  
Date Received06/01/1995
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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