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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 K102510
Device Name DIMENSIONS HB1C KIT, MODEL DF105A
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact ANNA MARIE ENNIS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact ANNA MARIE ENNIS
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJX  
Date Received08/27/2010
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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