Genetic Testing Institute: FDA clearances and approvals
Genetic Testing Institute has 6 FDA 510(k) clearances (first 1984, latest 2008), across 3 product codes in 2 review panels. Median 510(k) review time: 106 days. openFDA lists 2 product recalls by a recalling firm named Genetic Testing Institute.
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 |
|---|---|---|---|
| LCO | Platelet Factor 4 Radioimmunoassay | 3 | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
| DGX | Ng1m(A), Antigen, Antiserum, Control | 1 | 1 |
Review panels
- Hematology (5)
- Immunology (1)
Most recent Genetic Testing Institute 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082205 | FACTOR VIII ANTIBODY SCREEN | GGP | 2008-11-20 | 107 |
| K071781 | PF4 IGG | LCO | 2007-12-19 | 170 |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | LCO | 2006-01-20 | 30 |
| K993553 | GTI-FVIII INHIBITOR ASSAY | GGP | 2000-02-01 | 104 |
| K983379 | GTI-PF4 ELISA | LCO | 1999-03-09 | 165 |
| K841114 | ALLO-TYPE HUMAN IMMUNOGLOBULIN- | DGX | 1984-06-14 | 91 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-12-15.
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 Genetic Testing Institute have?
Genetic Testing Institute has 6 FDA 510(k) clearances (first 1984, latest 2008), across 3 product codes in 2 review panels.
How long does FDA take to clear Genetic Testing Institute's 510(k)s?
The median time from FDA receipt to decision across Genetic Testing Institute's cleared 510(k)s is 106 days.
What devices does Genetic Testing Institute make?
Its most frequent FDA product codes are LCO (Platelet Factor 4 Radioimmunoassay, 3); GGP (Test, Qualitative And Quantitative Factor Deficiency, 2); DGX (Ng1m(A), Antigen, Antiserum, Control, 1).
Has Genetic Testing Institute had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Genetic Testing Institute; the most recent began 2014-12-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Genetic Testing Institute clearances with predicates and recalls
- Run predicate analysis for product code LCO, Genetic Testing Institute'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.