GGQ · Test, Prothrombin Consumption
Hematology · 21 CFR 864.7720 · Class 2
Overview
| Product Code | GGQ |
|---|---|
| Device Name | Test, Prothrombin Consumption |
| Regulation | 21 CFR 864.7720 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K803081 | QUANTICHECK CONTROL PLASMA | Abbott Laboratories | Mar 17, 1981 | SESE |
| K800656 | A-GENT QUANTICHROM THROMBIGEN-E | Abbott Laboratories | May 30, 1980 | SESE |
Top Applicants
- Abbott Laboratories — 2 clearances
