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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 K951363
Device Name CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
Applicant
Immunoprobe, Inc.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact EDWARD C WILSON
Correspondent
Immunoprobe, Inc.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact EDWARD C WILSON
Regulation Number866.5660
Classification Product Code
MID  
Date Received03/24/1995
Decision Date 10/13/1995
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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