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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 K913054
Device Name 3M ANTI-CARDIOLIPIN FAST(TM) TEST
Applicant
3M Diagnostic Systems, Inc.
3380 Central Expressway
Santa Clara,  CA  95051
Applicant Contact SYLVIA ZORICH
Correspondent
3M Diagnostic Systems, Inc.
3380 Central Expressway
Santa Clara,  CA  95051
Correspondent Contact SYLVIA ZORICH
Regulation Number866.5660
Classification Product Code
MID  
Date Received07/09/1991
Decision Date 11/27/1991
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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