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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urinary homocystine (nonquantitative) test system
510(k) Number K073640
Device Name ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE, SCOTLAND,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIT   JJX  
Date Received12/26/2007
Decision Date 04/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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