LGJ — Fluorescence Polarization Immunoassay, Amibacin Class II
FDA Device Classification
Classification Details
- Product Code
- LGJ
- Device Class
- Class II
- Regulation Number
- 862.3035
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K991597 | roche diagnostics | COBAS INTEGRA AMIKACIN MAB | July 22, 1999 |
| K941712 | roche diagnostic systems | COBAS-FP REAGENTS AND CALIBRATORS | June 13, 1994 |
| K862248 | windsor laboratories | AMIKACIN KIT (FPIA) | August 4, 1986 |