LOO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reagent, Leishmanii Serological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3870
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KALAZAR DETECT (K023483) | Inbios Intl., Inc. | 2003-05-06 |
| AMIZYME-LEISHMANIA SPP. TEST KIT (K842526) | Amico Lab, Inc. | 1984-08-28 |
Track LOO automatically
Every clearance here is in the API, with alerts when new ones post.