Device |
system, test, combs, automated |
Regulation Description |
Automated Coombs test systems. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | KSM |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.9300
|
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 |
|
|