Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EliA ANA Positive Control 100 | 83-0006-91 | Phadia AB | JJY | 07333066013046 |
| EliA ANA Positive Control 250 | 83-0006-41 | Phadia AB | JJY | 07333066012995 |
| EliA dsDNA Well | DECC055000 | Phadia AB | LSW | 07333066019406 |