Panels › Clinical Toxicology › Product code LFW · Class 2
Fluorescence Polarization Immunoassay, Tobramycin
Regulation 862.3900
0510(k)s in 12 months (10 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LFW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 4, 1997 | K964670 | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN Roche Diagnostic Systems, Inc. | LFW |
| Nov 10, 1994 | K944371 | TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR Sigma Diagnostics, Inc. | LFW |
| Aug 18, 1994 | K941614 | AXSYM TOBRAMYCIN Abbott Laboratories | LFW |
| Jul 26, 1991 | K912143 | CEDIA(R) TOBRAMYCIN ASSAY Microgenics Corp. | LFW |
| Apr 20, 1990 | K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LFW |
| Sep 1, 1989 | K894531 | FPR TOBRAMYCIN KIT Colony Laboratories, Inc. | LFW |
| Aug 17, 1987 | K872562 | INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET Innotron of Oregon, Inc. | LFW |
| Dec 5, 1985 | K854392 | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU Windsor Laboratories, Inc. | LFW |
| Feb 1, 1985 | K843828 | COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA Roche Diagnostic Systems, Inc. | LFW |
| May 31, 1984 | K841866 | INNOFLOUR TOBRAMYCIN Innotron Diagnostics | LFW |
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