Device Classification Name |
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
|
510(k) Number |
K023240 |
Device Name |
ST AIA-PACK CA 19-9 |
Applicant |
TOSOH CORP. |
73 COGWHEEL LN. |
SEYMOUR,
CT
06483
|
|
Applicant Contact |
JUDITH E LOEBEL |
Correspondent |
TOSOH CORP. |
73 COGWHEEL LN. |
SEYMOUR,
CT
06483
|
|
Correspondent Contact |
JUDITH E LOEBEL |
Regulation Number | 866.6010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/27/2002 |
Decision Date | 12/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|