Oxis Intl., Inc.: FDA clearances and approvals
Oxis Intl., Inc. has 11 FDA 510(k) clearances (first 1995, latest 1997), across 10 product codes in 2 review panels. Median 510(k) review time: 65 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 2 | 2 |
| DLJ | Calibrators, Drug Specific | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 | 1 |
| LAS | Drug Specific Control Materials | 1 | 1 |
| LBZ | Enzyme Immunoassay, Quinidine | 1 | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 | 1 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 1 | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 | 1 |
| MSL | System, Test, Topiramatee | 1 | 1 |
Review panels
- Clinical Toxicology (10)
- Microbiology (1)
Most recent Oxis Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972331 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | LGQ | 1997-08-01 | 39 |
| K972330 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM | LGQ | 1997-07-14 | 21 |
| K970517 | INNOFLUOR TOPIRAMATE CONTROL SET | LAS | 1997-05-12 | 90 |
| K970510 | INNOFLOUR TOPIRAMATE REAGENT SET | MSL | 1997-05-12 | 90 |
| K970509 | INNOFLOUR CALIBRATOR REAGENT SET | DLJ | 1997-05-12 | 90 |
| K955568 | INNOFLUOR QUINIDINE ASSAY SYSTEM | LBZ | 1996-04-04 | 120 |
| K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM | KLQ | 1996-02-09 | 65 |
| K955569 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | LCQ | 1996-02-09 | 65 |
| K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | LGS | 1996-01-24 | 49 |
| K955562 | INNOFLUOR PHENYTOIN ASSAY SYSTEM | LGR | 1996-01-24 | 49 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oxis Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Oxis Intl., Inc. have?
Oxis Intl., Inc. has 11 FDA 510(k) clearances (first 1995, latest 1997), across 10 product codes in 2 review panels.
How long does FDA take to clear Oxis Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Oxis Intl., Inc.'s cleared 510(k)s is 65 days.
What devices does Oxis Intl., Inc. make?
Its most frequent FDA product codes are LGQ (Fluorescence Polarization Immunoassay, Phenobarbital, 2); DLJ (Calibrators, Drug Specific, 1); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 1).
Has Oxis Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Oxis Intl., Inc. Related entities may recall under other names.
Next steps
- See all 11 Oxis Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LGQ, Oxis Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.