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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 K921183
Device Name DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
Applicant
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Applicant Contact GEORGE ZAJICEK
Correspondent
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Correspondent Contact GEORGE ZAJICEK
Regulation Number866.5090
Classification Product Code
DBM  
Date Received03/09/1992
Decision Date 06/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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