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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Antigen, Antiserum, Control
510(k) Number K081299
Device Name DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Applicant Contact RADAMES RIESGO
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Correspondent Contact RADAMES RIESGO
Regulation Number866.5880
Classification Product Code
DDG  
Subsequent Product Codes
JIX   JJY  
Date Received05/08/2008
Decision Date 08/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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