Fairleigh Dickinson Laboratories, Inc.: FDA clearances and approvals
Fairleigh Dickinson Laboratories, Inc. has 7 FDA 510(k) clearances (first 1985, latest 1990), across 5 product codes in 1 review panel. Median 510(k) review time: 74 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 |
|---|---|---|---|
| KZJ | Device, Gas Generating | 2 | 2 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 2 | 2 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| JTW | System, Transport, Aerobic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (6)
Most recent Fairleigh Dickinson Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896032 | MODIFIED ELISA FOR CHLAMYDIA | LJC | 1990-01-29 | 105 |
| K895187 | FDL, INC.'S TRANSPORT SYSTEM | JTW | 1989-10-24 | 74 |
| K883266 | FDL ELISA FOR CHLAMYDIA | LJC | 1988-10-25 | 83 |
| K881502 | BREWER GEL FOR CAMPYLOBACTER | KZJ | 1988-04-27 | 16 |
| K875362 | BREWER GEL FOR ANAEROBES | KZJ | 1988-01-27 | 27 |
| K853307 | DIRECT ELISA FOR HERPES SIMPLEX VIRUS | GQN | 1985-12-23 | 138 |
| K850251 | ROTALOK SURGICAL HAND TABLE | — | 1985-02-28 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Fairleigh Dickinson Laboratories, 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 Fairleigh Dickinson Laboratories, Inc. have?
Fairleigh Dickinson Laboratories, Inc. has 7 FDA 510(k) clearances (first 1985, latest 1990), across 5 product codes in 1 review panel.
How long does FDA take to clear Fairleigh Dickinson Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Fairleigh Dickinson Laboratories, Inc.'s cleared 510(k)s is 74 days.
What devices does Fairleigh Dickinson Laboratories, Inc. make?
Its most frequent FDA product codes are KZJ (Device, Gas Generating, 2); LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), 2); GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, 1).
Has Fairleigh Dickinson Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fairleigh Dickinson Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 7 Fairleigh Dickinson Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KZJ, Fairleigh Dickinson Laboratories, 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.