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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
Predetermined Change
Control Plan Authorized		 No
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