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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 K083222
Device Name AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Code
JIT  
Date Received11/03/2008
Decision Date 07/31/2009
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
Recalls CDRH Recalls
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