Device |
hemoglobin for donor testing |
Regulation Description |
Whole blood hemoglobin assays. |
Definition |
Assays hemoglobin concentration test for blood donors. |
Physical State |
Pulse oximeter. |
Technical Method |
Pulse oximetry of blood samples. |
Target Area |
Clinical whole blood. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | QGU |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.7500
|
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
|
Third Party Review |
Not Third Party Eligible |