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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K062467
Device Name AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact ERICA CONWAY
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact ERICA CONWAY
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
JIT   JJX  
Date Received08/24/2006
Decision Date 11/22/2006
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
Predetermined Change
Control Plan Authorized		 No
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