AutoGenomics, Inc.: FDA clearances and approvals
AutoGenomics, Inc. has 1 FDA 510(k) clearance (first 2007, latest 2007), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time: 341 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 |
|---|---|---|---|
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 1 | 1 |
| QZH | Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit | 1 | 0 |
Review panels
- Pathology (1)
- Clinical Toxicology (1)
Most recent AutoGenomics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060564 | INFINITI SYSTEM | NPQ | 2007-02-07 | 341 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230032 | PMA | AvertD and AvertD Buccal Sample Collection Kit | 2023-12-19 |
Recalls
openFDA lists no recalls under a recalling firm named AutoGenomics, 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 AutoGenomics, Inc. have?
AutoGenomics, Inc. has 1 FDA 510(k) clearance (first 2007, latest 2007), plus 1 PMA decision, across 2 product codes in 2 review panels.
How long does FDA take to clear AutoGenomics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across AutoGenomics, Inc.'s cleared 510(k)s is 341 days.
What devices does AutoGenomics, Inc. make?
Its most frequent FDA product codes are NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr, 1); QZH (Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit, 1).
Has AutoGenomics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching AutoGenomics, Inc. Related entities may recall under other names.
Next steps
- See all 1 AutoGenomics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NPQ, AutoGenomics, 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.