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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230
510(k) Number K071961
Device Name MESACUP MODELS BP180 AND BP230 ELISA KITS
Applicant
MBL INTERNATIONAL CORPORATION
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
MBL INTERNATIONAL CORPORATION
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number866.5660
Classification Product Code
OEG  
Date Received07/16/2007
Decision Date 08/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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