LFW
10 FDA 510(k) clearances · Product code
67 daysmedian time to decision
136 days90th percentile
10clearances measured
FDA profile
- Official device name
- Fluorescence Polarization Immunoassay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- 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 |
|---|---|---|
| ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (K964670) | Roche Diagnostic Systems, Inc. | 1997-02-04 |
| TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (K944371) | Sigma Diagnostics, Inc. | 1994-11-10 |
| AXSYM TOBRAMYCIN (K941614) | Abbott Laboratories | 1994-08-18 |
| CEDIA(R) TOBRAMYCIN ASSAY (K912143) | Microgenics Corp. | 1991-07-26 |
| MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (K900707) | Innotron of Oregon, Inc. | 1990-04-20 |
| FPR TOBRAMYCIN KIT (K894531) | Colony Laboratories, Inc. | 1989-09-01 |
| INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET (K872562) | Innotron of Oregon, Inc. | 1987-08-17 |
| TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (K854392) | Windsor Laboratories, Inc. | 1985-12-05 |
| COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (K843828) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| INNOFLOUR TOBRAMYCIN (K841866) | Innotron Diagnostics | 1984-05-31 |
Track LFW automatically
Every clearance here is in the API, with alerts when new ones post.