| Device Type ID | 2419 |
| Device Name | Kit, Igg, Platelet Associated |
| Regulation Description | Multipurpose System For In Vitro Coagulation Studies. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5425 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LLG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2419 |
| Device | Kit, Igg, Platelet Associated |
| Product Code | LLG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multipurpose System For In Vitro Coagulation Studies. |
| CFR Regulation Number | 864.5425 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Medical Solutions USA, Inc | II | Sep-14-2016 |