Innotron of Oregon, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Innotron of Oregon, Inc.” (first 1980, latest 1990), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 51 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | 10 | 10 |
| LBZ | Enzyme Immunoassay, Quinidine | 2 | 2 |
| LEH | Radioimmunoassay, Vancomycin | 2 | 2 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 2 | 2 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 2 | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| KHO | Fluorometer, For Clinical Use | 1 | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Innotron of Oregon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET | DLJ | 1990-08-22 | 40 |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | KLQ | 1990-08-09 | 27 |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | LFW | 1990-04-20 | 67 |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | LEH | 1990-04-19 | 66 |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | LGS | 1990-04-12 | 59 |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | LBZ | 1990-04-12 | 59 |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | LGQ | 1990-04-12 | 59 |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | LCD | 1990-04-12 | 59 |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | LGI | 1990-04-12 | 59 |
| K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | LGR | 1989-10-31 | 29 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innotron of Oregon, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Innotron Diagnostics (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innotron of Oregon, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Innotron of Oregon, Inc.” (first 1980, latest 1990), across 15 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innotron of Oregon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innotron of Oregon, Inc. is 51 days.
Which FDA product codes appear under Innotron of Oregon, Inc.?
The most frequent FDA product codes under this applicant name are DLJ (Calibrators, Drug Specific, 10); LBZ (Enzyme Immunoassay, Quinidine, 2); LEH (Radioimmunoassay, Vancomycin, 2).
Next steps
- See all 28 Innotron of Oregon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DLJ, Innotron of Oregon, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.