Invitrogen Corporation: FDA clearances and approvals
Invitrogen Corporation has 1 FDA 510(k) clearance (first 2002, latest 2002), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time: 179 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 |
|---|---|---|---|
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | 1 | 1 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 1 | 0 |
Review panels
Most recent Invitrogen Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | NDS | 2002-12-23 | 179 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050040 | PMA | SPOT-LIGHT HER2 CISH KIT | 2008-07-01 |
Recalls
openFDA lists no recalls under a recalling firm named Invitrogen Corporation.
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 Invitrogen Corporation have?
Invitrogen Corporation has 1 FDA 510(k) clearance (first 2002, latest 2002), plus 1 PMA decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Invitrogen Corporation's 510(k)s?
The median time from FDA receipt to decision across Invitrogen Corporation's cleared 510(k)s is 179 days.
What devices does Invitrogen Corporation make?
Its most frequent FDA product codes are NDS (Media, Culture, Ex Vivo, Tissue And Cell, 1); NYQ (Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer, 1).
Has Invitrogen Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Invitrogen Corporation. Related entities may recall under other names.
Next steps
- See all 1 Invitrogen Corporation clearances with predicates and recalls
- Run predicate analysis for product code NDS, Invitrogen Corporation'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.