Device |
instrument, coagulation |
Regulation Description |
Coagulation instrument. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | KQG |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
864.5400
|
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
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|
|
|