Denley Instruments, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Denley Instruments, Inc.” (first 1989, latest 1992), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 | 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 8 | 8 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
Review panels
Most recent Denley Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922803 | WELLWASH 4 MARK II | JQW | 1992-11-05 | 148 |
| K922327 | DENLEY WELLPREP 2 SAMPLE PROCESSOR | JQW | 1992-08-12 | 93 |
| K922183 | WELLPREP 2000 SAMPLE PROCESSOR | JQW | 1992-08-11 | 92 |
| K915284 | STACKING MICROPLATE WASHER | JQW | 1992-01-22 | 58 |
| K913567 | WELLPREP 1 | JQW | 1991-10-04 | 56 |
| K900599 | MICROPLATE REAGENT DISPENSER | JQW | 1990-05-17 | 98 |
| K894272 | DENLEY WELLDILL 3 | JQW | 1989-08-21 | 60 |
| K894270 | DENLEY ANTHOS 2001 READER | JJQ | 1989-08-21 | 60 |
| K894271 | DENLEY WELLWASH 2 AND 4 | JQW | 1989-08-15 | 54 |
Recalls
openFDA lists no recalls under a recalling firm named Denley Instruments, Inc..
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 Denley Instruments, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Denley Instruments, Inc.” (first 1989, latest 1992), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Denley Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Denley Instruments, Inc. is 60 days.
Which FDA product codes appear under Denley Instruments, Inc.?
The most frequent FDA product codes under this applicant name are JQW (Station, Pipetting And Diluting, For Clinical Use, 8); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 1).
Next steps
- See all 9 Denley Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JQW, Denley Instruments, Inc.'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.