Immunicon Corp.: FDA clearances and approvals
Immunicon Corp. has 6 FDA 510(k) clearances (first 2002, latest 2006), across 4 product codes in 3 review panels. Median 510(k) review time: 60 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 |
|---|---|---|---|
| GKH | Apparatus, Automated Blood Cell Diluting | 2 | 2 |
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | 2 | 2 |
| GKZ | Counter, Differential Cell | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
Review panels
- Hematology (3)
- Pathology (2)
- Clinical Chemistry (1)
Most recent Immunicon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060110 | CELLTRACKS ANALYZER II | NQI | 2006-03-16 | 58 |
| K050145 | CELLTRACKA ANALYZER II | NQI | 2005-03-15 | 50 |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | GKH | 2004-03-12 | 58 |
| K030263 | IMMUNICON CELLTRACKS ANALYZER | GKZ | 2003-11-24 | 301 |
| K030596 | IMMUNICON CELLSAVE PRESERVATIVE TUBE | JKA | 2003-08-08 | 164 |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | GKH | 2002-09-30 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Immunicon Corp..
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 Immunicon Corp. have?
Immunicon Corp. has 6 FDA 510(k) clearances (first 2002, latest 2006), across 4 product codes in 3 review panels.
How long does FDA take to clear Immunicon Corp.'s 510(k)s?
The median time from FDA receipt to decision across Immunicon Corp.'s cleared 510(k)s is 60 days.
What devices does Immunicon Corp. make?
Its most frequent FDA product codes are GKH (Apparatus, Automated Blood Cell Diluting, 2); NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration, 2); GKZ (Counter, Differential Cell, 1).
Has Immunicon Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Immunicon Corp. Related entities may recall under other names.
Next steps
- See all 6 Immunicon Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKH, Immunicon Corp.'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.