Definition: To Estimate PK Profile And Dosing Calculation.
| Device Type ID | 2236 |
| Device Name | Sparse Sample Pk Profile And Dosing Software |
| Physical State | Solid |
| Technical Method | Software Driven |
| Target Area | Blood |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2236 |
| Device | Sparse Sample Pk Profile And Dosing Software |
| Product Code | PHY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| CFR Regulation Number | 868.1890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BAXALTA US INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |