| Device |
acid hematin |
| Regulation Description |
Whole blood hemoglobin assays. |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Hematology |
| Product Code | GGF |
| Submission Type |
510(k)
|
| Regulation Number |
864.7500
|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
|
Third Party Review
|
Accredited Persons
|
|
|