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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 K001574
Device Name DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
Applicant
Axis-Shield
The Technology Park
Juna Place
Dundee Tayside, Scotland,  GB DD2 1XA
Applicant Contact EILEEN A MCCAFFERTY
Correspondent
Axis-Shield
The Technology Park
Juna Place
Dundee Tayside, Scotland,  GB DD2 1XA
Correspondent Contact EILEEN A MCCAFFERTY
Regulation Number866.5660
Classification Product Code
MID  
Date Received05/22/2000
Decision Date 06/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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