Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K091845
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM · Phadia US, Inc. · decided 2010-06-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EliA Cardiolipin IgG Well | DECC055290 | Phadia AB | MID | 07333066014722 |
| EliA APS Positive Control 250 | 83-0008-01 | Phadia AB | JJY | 07333066019994 |
| EliA APS Positive Control 100 | 83-0007-91 | Phadia AB | JJY | 07333066019987 |
| EliA IgM Curve Control Strip | 83-0006-31 | Phadia AB | JJY | 07333066012988 |
| EliA IgM Curve Control | 83-0006-01 | Phadia AB | JJY | 07333066012957 |
| EliA IgM Calibrator Well | DECC066270 | Phadia AB | JJY | 07333066024271 |
| EliA Cardiolipin IgM Well | DECC055300 | Phadia AB | MID | 07333066014739 |
| EliA IgM Conjugate | 83-0004-91 | Phadia AB | JJY | 07333066012889 |
| EliA IgM Conjugate 50 | 83-0006-11 | Phadia AB | JJY | 07333066012964 |
| EliA ß2-Glycoprotein I IgM Well | DECC055330 | Phadia AB | MSV | 07333066014760 |
| EliA IgM Calibrators | 83-1049-01 | Phadia AB | JJY | 07333066020082 |
| EliA ß2-Glycoprotein I IgG Well | DECC055320 | Phadia AB | MSV | 07333066014753 |
| EliA IgM Calibrator Strip | 83-0006-21 | Phadia AB | JJY | 07333066012971 |
| EliA IgM Calibrator Well | DECC055270 | Phadia AB | JJY | 07333066014708 |