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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 K001981
Device Name DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
Applicant
AXIS-SHIELD LTD.
THE TECHNOLOGY PARK
DUNDEE, TAYSIDE, SCOTLAND,  GB DD21XA
Applicant Contact EILEEN MCCAFFERTY
Correspondent
AXIS-SHIELD LTD.
THE TECHNOLOGY PARK
DUNDEE, TAYSIDE, SCOTLAND,  GB DD21XA
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number866.5660
Classification Product Code
MID  
Date Received06/29/2000
Decision Date 08/21/2000
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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