LGJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fluorescence Polarization Immunoassay, Amibacin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3035
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA AMIKACIN MAB (K991597) | Roche Diagnostics Corp. | 1999-07-22 |
| COBAS-FP REAGENTS AND CALIBRATORS (K941712) | Roche Diagnostic Systems, Inc. | 1994-06-13 |
| AMIKACIN KIT (FPIA) (K862248) | Windsor Laboratories, Inc. | 1986-08-04 |
Track LGJ automatically
Every clearance here is in the API, with alerts when new ones post.