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 Number | 866.6010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/12/2010 |
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
|
|
|