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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 K102045
Device Name DIMENSION VISA HBA1C, MODEL K3105A
Applicant
SIEMENS HEATLHCARE DIAGNOSTICS INC
500 GBC DRIVE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact ANNA-MARIE K ENNIS
Correspondent
SIEMENS HEATLHCARE DIAGNOSTICS INC
500 GBC DRIVE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact ANNA-MARIE K ENNIS
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JIT  
Date Received07/21/2010
Decision Date 02/14/2011
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
Recalls CDRH Recalls
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