LFW — Fluorescence Polarization Immunoassay, Tobramycin Class II
FDA Device Classification
Classification Details
- Product Code
- LFW
- Device Class
- Class II
- Regulation Number
- 862.3900
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K964670 | roche diagnostic systems | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | February 4, 1997 |
| K944371 | sigma diagnostics | TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR | November 10, 1994 |
| K941614 | abbott laboratories | AXSYM TOBRAMYCIN | August 18, 1994 |
| K912143 | microgenics | CEDIA(R) TOBRAMYCIN ASSAY | July 26, 1991 |
| K900707 | innotron of oregon | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | April 20, 1990 |
| K894531 | colony laboratories | FPR TOBRAMYCIN KIT | September 1, 1989 |
| K872562 | innotron of oregon | INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET | August 17, 1987 |
| K854392 | windsor laboratories | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU | December 5, 1985 |
| K843828 | roche diagnostic systems | COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA | February 1, 1985 |
| K841866 | innotron diagnostics | INNOFLOUR TOBRAMYCIN | May 31, 1984 |