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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anti-rnp antibody, antigen and control
510(k) Number K905194
Device Name DIASTAT ANTI-RO (SS-A)
Applicant
SHIELD DIAGNOSTICS, LTD.
TECHNOLOGY PARK DUNDEE
DD2 1SW
SCOTLAND,  KN 77359
Applicant Contact GEORGE ZAJICEK
Correspondent
SHIELD DIAGNOSTICS, LTD.
TECHNOLOGY PARK DUNDEE
DD2 1SW
SCOTLAND,  KN 77359
Correspondent Contact GEORGE ZAJICEK
Regulation Number866.5100
Classification Product Code
LKO  
Date Received11/19/1990
Decision Date 12/13/1990
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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