Device |
activated partial thromboplastin |
Regulation Description |
Partial thromboplastin time tests. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | GFO |
Premarket Review |
Office of In Vitro Diagnostics and Radiological Health
(OIR)
|
Submission Type |
510(k)
|
Regulation Number |
864.7925
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Recognized Consensus Standards
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|