GOE
7 FDA 510(k) clearances · Product code
616 daysmedian time to decision
617 days90th percentile
7clearances measured
FDA profile
- Official device name
- Antisera, Fluorescent, Poliovirus 1-3
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3405
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (K940026) | Light Diagnostics | 1995-09-12 |
| ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (K940027) | Chemicon Intl., Inc. | 1995-09-12 |
| ENTEROVIRUS 71 MONOCLONAL ANTIBODY (K940473) | Chemicon Intl., Inc. | 1995-09-12 |
| POLIOVIRUS 2 MONOCLONAL ANTIBODY (K940034) | Light Diagnostics | 1995-09-12 |
| POLIOVIRUS 3 MONOCLONAL ANTIBODY (K940017) | Light Diagnostics | 1995-09-12 |
| POLIOVIRUS 1 MONOCLONAL ANTIBODY (K940018) | Light Diagnostics | 1995-09-08 |
| ENTEROVIRUS 70 MONCLONAL ANTIBODY (K940363) | Light Diagnostics | 1995-09-08 |
Track GOE automatically
Every clearance here is in the API, with alerts when new ones post.