Innotron Diagnostics: FDA clearances and approvals
Innotron Diagnostics has 6 FDA 510(k) clearances (first 1984, latest 1985), across 6 product codes in 2 review panels. Median 510(k) review time: 28 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 |
|---|---|---|---|
| LCQ | Fluorescent Immunoassay Gentamicin | 1 | 1 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 1 | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 1 | 1 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 1 | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 | 1 |
Review panels
- Clinical Toxicology (5)
- Microbiology (1)
Most recent Innotron Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850629 | INNOFLUOR THEOPHYLLINE | LGS | 1985-03-12 | 21 |
| K844721 | INNOFLUOR PRIMIDONE | LKT | 1985-01-08 | 35 |
| K841866 | INNOFLOUR TOBRAMYCIN | LFW | 1984-05-31 | 27 |
| K841865 | INNOFLOUR GENTAMICIN | LCQ | 1984-05-31 | 27 |
| K841707 | INNOFLUOR PHENOBARBITAL | LGQ | 1984-05-23 | 30 |
| K841706 | INNOFLUOR PHENYTOIN | LGR | 1984-05-22 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Innotron Diagnostics.
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 Innotron Diagnostics have?
Innotron Diagnostics has 6 FDA 510(k) clearances (first 1984, latest 1985), across 6 product codes in 2 review panels.
How long does FDA take to clear Innotron Diagnostics's 510(k)s?
The median time from FDA receipt to decision across Innotron Diagnostics's cleared 510(k)s is 28 days.
What devices does Innotron Diagnostics make?
Its most frequent FDA product codes are LCQ (Fluorescent Immunoassay Gentamicin, 1); LFW (Fluorescence Polarization Immunoassay, Tobramycin, 1); LGQ (Fluorescence Polarization Immunoassay, Phenobarbital, 1).
Has Innotron Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching Innotron Diagnostics. Related entities may recall under other names.
Next steps
- See all 6 Innotron Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code LCQ, Innotron Diagnostics'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.