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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K020156
Device Name DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
LUNA PLACE
DUNDEE, SCOTLAND,  GB DD2 1XA
Applicant Contact EILEEN MCCAFFERTY
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
LUNA PLACE
DUNDEE, SCOTLAND,  GB DD2 1XA
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number866.5660
Classification Product Code
MID  
Date Received01/17/2002
Decision Date 03/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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