Veridex, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Veridex, LLC” (first 2004, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 2 | 215 |
| 2013 | 1 | 90 |
| 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 |
|---|---|---|---|
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | 10 | 10 |
| GKH | Apparatus, Automated Blood Cell Diluting | 1 | 1 |
| NRS | Control Material, Blood Circulating Epithelial Cancer Cell | 1 | 1 |
Review panels
- Pathology (10)
- Hematology (2)
Most recent Veridex, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | NQI | 2013-06-20 | 90 |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | NQI | 2012-12-13 | 90 |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | NQI | 2012-01-20 | 340 |
| K113181 | CELLTRACKS ANALYER II | NQI | 2011-12-12 | 45 |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | NQI | 2010-12-21 | 22 |
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | GKH | 2010-08-26 | 169 |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | 2008-02-26 | 90 |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | 2007-11-20 | 148 |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | 2006-12-14 | 150 |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | 2005-10-27 | 77 |
2 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2015-05-15.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Veridex, LLC?
FDA lists 12 510(k) clearances under the applicant name “Veridex, LLC” (first 2004, latest 2013), across 3 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 Veridex, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Veridex, LLC is 90 days.
Which FDA product codes appear under Veridex, LLC?
The most frequent FDA product codes under this applicant name are NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration, 10); GKH (Apparatus, Automated Blood Cell Diluting, 1); NRS (Control Material, Blood Circulating Epithelial Cancer Cell, 1).
Next steps
- See all 12 Veridex, LLC clearances with predicates and recalls
- Run predicate analysis for product code NQI, Veridex, LLC'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.