Panels › Immunology › Product code OBE · Class 2
Anti-Ss-A 52 Autoantibodies
Regulation 866.5100
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OBE
| Company | 510(k)s | Recalls |
|---|---|---|
| Inova Diagnostics, Inc. | 2 | 0 |
| Zeus Scientific | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2026 | K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB Zeus Scientific | OBE |
| Mar 5, 2015 | K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS Inova Diagnostics, Inc. | OBE |
| Apr 4, 2007 | K063565 | QUANTA LITE SS-A 52 ELISA Inova Diagnostics, Inc. | OBE |
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