LFW — Fluorescence Polarization Immunoassay, Tobramycin Class II
FDA product code LFW covers "Fluorescence Polarization Immunoassay, Tobramycin", a Class II medical device regulated under 21 CFR 862.3900. Submissions are reviewed by the Clinical Toxicology panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |