Device |
instrument, hematocrit, automated |
Regulation Description |
Automated hematocrit instrument. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | GKF |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.5600
|
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 |
Not Third Party Eligible |
|
|