Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K140225
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO · Phadia US, Inc. · decided 2014-10-27 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EliA ANCA/GBM Positive Control 250 | 83-0006-51 | Phadia AB | JJY | 07333066013008 |
| EliA MPOS Well | DECC055370 | Phadia AB | MOB | 07333066014784 |
| EliA ANCA/GBM Positive Control 100 | 83-0007-01 | Phadia AB | JJY | 07333066013053 |
| EliA PR3S Well | DECC055360 | Phadia AB | MOB | 07333066014777 |
| EliA GBM Well | DECC055140 | Phadia AB | MVJ | 07333066014630 |