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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K071466
Device Name DCA VANTAGE, MODEL 5075
Applicant
Siemens Medical Solutions Diagnostics
2 Edgewater Dr.
Norowood,  MA  02062
Applicant Contact NOOR MALKI
Correspondent
Siemens Medical Solutions Diagnostics
2 Edgewater Dr.
Norowood,  MA  02062
Correspondent Contact NOOR MALKI
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
CGX   JIR  
Date Received05/29/2007
Decision Date 10/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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
Recalls CDRH Recalls
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