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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K912291
Device Name DISTAT ANTI-SCL-70 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 Number866.5100
Classification Product Code
LKJ  
Date Received05/23/1991
Decision Date 07/30/1991
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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