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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K940251
Device Name MITOCHONDRIA EIA TEST KIT
Applicant
David A. Fuccillo, Ph.D.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
David A. Fuccillo, Ph.D.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number866.5090
Classification Product Code
DBM  
Date Received01/19/1994
Decision Date 05/03/1994
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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