Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Syva® Emit® Calibrator/Control Level 5 | 10445411 | Siemens Healthcare Diagnostics Inc. | DIF DKB | 00842768001789 |
| Syva® Emit® Calibrator/Control Level 4 | 10445410 | Siemens Healthcare Diagnostics Inc. | DIF DKB | 00842768001772 |
| Syva® Emit® Calibrator/Control Level 1 | 10445407 | Siemens Healthcare Diagnostics Inc. | DIF DKB | 00842768001741 |
| Syva® Emit® Calibrator/Control Level 0 (negative) | 10445406 | Siemens Healthcare Diagnostics Inc. | DIF DKB | 00842768001734 |
| Syva® Emit® Calibrator/Control Level 3 | 10445409 | Siemens Healthcare Diagnostics Inc. | DIF DKB | 00842768001765 |
| Syva® Emit® Calibrator/Control Level 2 | 10445408 | Siemens Healthcare Diagnostics Inc. | DIF DKB | 00842768001758 |