| Device Type ID | 2384 |
| Device Name | Calibrator For Cell Indices |
| Regulation Description | Calibrator For Cell Indices. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.8150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2384 |
| Device | Calibrator For Cell Indices |
| Product Code | KRX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Calibrator For Cell Indices. |
| CFR Regulation Number | 864.8150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STRECK | ||
SUBSTANTIALLY EQUIVALENT | 3 | |