Company ยท US
Oxis Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1997. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 2 |
| DLJ | Calibrators, Drug Specific | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 |
| LAS | Drug Specific Control Materials | 1 |
| LBZ | Enzyme Immunoassay, Quinidine | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 |
| MSL | System, Test, Topiramatee | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 1997 | K972331 | INNOFLUOR GENTAMICIN ASSAY SYSTEM Oxis Intl., Inc. | LGQ |
| Jul 14, 1997 | K972330 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM Oxis Intl., Inc. | LGQ |
| May 12, 1997 | K970517 | INNOFLUOR TOPIRAMATE CONTROL SET Oxis Intl., Inc. | LAS |
| May 12, 1997 | K970510 | INNOFLOUR TOPIRAMATE REAGENT SET Oxis Intl., Inc. | MSL |
| May 12, 1997 | K970509 | INNOFLOUR CALIBRATOR REAGENT SET Oxis Intl., Inc. | DLJ |
| Apr 4, 1996 | K955568 | INNOFLUOR QUINIDINE ASSAY SYSTEM Oxis Intl., Inc. | LBZ |
| Feb 9, 1996 | K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM Oxis Intl., Inc. | KLQ |
| Feb 9, 1996 | K955569 | INNOFLUOR GENTAMICIN ASSAY SYSTEM Oxis Intl., Inc. | LCQ |
| Jan 24, 1996 | K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM Oxis Intl., Inc. | LGS |
| Jan 24, 1996 | K955562 | INNOFLUOR PHENYTOIN ASSAY SYSTEM Oxis Intl., Inc. | LGR |
| May 5, 1995 | K950346 | B-L RED(TM) DISCS Oxis Intl., Inc. | JTO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||