GNM
9 FDA 510(k) clearances · Product code
617 daysmedian time to decision
627 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3145
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (K936254) | Light Diagnostics | 1995-09-08 |
| COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY (K936251) | Light Diagnostics | 1995-09-08 |
| ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS (K936073) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (K940471) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY (K936089) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY (K936252) | Light Diagnostics | 1995-09-08 |
| COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (K936253) | Light Diagnostics | 1995-09-08 |
| COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (K940472) | Chemicon Intl., Inc. | 1995-09-08 |
| COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (K936145) | Chemicon Intl., Inc. | 1995-09-08 |
Track GNM automatically
Every clearance here is in the API, with alerts when new ones post.