Device |
system, test, fibrin/fibrinogen degradation products for monitoring of colorectal cancer |
Regulation Description |
Tumor-associated antigen immunological test system. |
Definition |
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES. |
Regulation Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | NTY |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
866.6010
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|