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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 K093631
Device Name B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Applicant Contact ANNA MARIE KATHLEEN ENNIS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
Ms 514
Newark,  DE  19702
Correspondent Contact ANNA MARIE KATHLEEN ENNIS
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Code
CGN  
Date Received11/24/2009
Decision Date 02/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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