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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
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