Device |
fibrin split products |
Regulation Description |
Fibrinogen/fibrin degradation products assay. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | GHH |
Premarket Review |
Division of Immunology and Hematology Devices
(DIHD)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
864.7320
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review
|
Accredited Persons
|