Oxis Intl., Inc.
Medical device manufacturer in Portland, OR.
11510(k) clearances
0PMA approvals
0recalls
Device types
- LGQ Fluorescence Polarization Immunoassay… 2
- JTO Discs, Strips And Reagents, Microorganism… 1
- LGR Fluorescence Polarization Immunoassay… 1
- LGS Fluorescence Polarization Immunoassay… 1
- LCQ Fluorescent Immunoassay Gentamicin 1
- KLQ Radioimmunoassay, Amikacin 1
- LBZ Enzyme Immunoassay, Quinidine 1
- DLJ Calibrators, Drug Specific 1
- MSL System, Test, Topiramatee 1
- LAS Drug Specific Control Materials 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | 07/14/1997SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | 05/12/1997SE |
| K970510 | Innoflour Topiramate Reagent SetMSL · Traditional | 05/12/1997SE |
| K970509 | Innoflour Calibrator Reagent SetDLJ · Traditional | 05/12/1997SE |
| K955568 | Innofluor Quinidine Assay SystemLBZ · Traditional | 04/04/1996SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | 02/09/1996SE |
| K955569 | Innofluor Gentamicin Assay SystemLCQ · Traditional | 02/09/1996SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | 01/24/1996SE |
| K955562 | Innofluor Phenytoin Assay SystemLGR · Traditional | 01/24/1996SE |
| K950346 | B-L Red(Tm) DiscsJTO · Traditional | 05/05/1995SE |