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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
510(k) Number K100375
Device Name DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
Applicant
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Applicant Contact PAMELA JURGA
Correspondent
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Correspondent Contact PAMELA JURGA
Regulation Number866.6010
Classification Product Code
NIG  
Subsequent Product Code
JIT  
Date Received02/12/2010
Decision Date 04/06/2011
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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