Sweden Diagnostics (Germany) GmbH
FDA 510(k) & PMA Approved Devices — 8 products
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Total Devices8
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | LJM | 2005-06-28 | View |
| 510(k) | K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | LJM | 2005-04-26 | View |
| 510(k) | K042629 | VARELISA SM ANTIBODIES, MODEL 18296 | LKP | 2004-12-08 | View |
| 510(k) | K041357 | VARELISA GLIADIN IGG ANTIBODIES | MST | 2004-08-02 | View |
| 510(k) | K041173 | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 | MVM | 2004-08-02 | View |
| 510(k) | K041174 | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 | MVM | 2004-07-19 | View |
| 510(k) | K041354 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 | MST | 2004-07-16 | View |
| 510(k) | K041040 | VARELISA MPO ANCA, MODEL 17648/17696 | MOB | 2004-06-16 | View |
No matching devices.
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