Digene Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Digene Corp.” (first 1997, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 183 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 |
|---|---|---|---|
| LSK | Dna-Reagents, Chlamydia | 3 | 3 |
| LSL | Dna-Reagents, Neisseria | 3 | 3 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| LJO | Antigen, Iha, Cytomegalovirus | 1 | 1 |
Review panels
Most recent Digene Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | LSK | 2001-09-25 | 183 |
| K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 | LSL | 2001-09-24 | 182 |
| K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | LSK | 2001-09-24 | 182 |
| K981567 | HYBRID CAPTURE II CT/GC TEST | LSL | 2000-02-29 | 669 |
| K981485 | HYBRID CAPTURE II GC-ID | LSL | 1999-11-29 | 584 |
| K990023 | HYBRID CAPTURE II CT-ID TEST | LSK | 1999-10-25 | 293 |
| K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | LJO | 1998-09-29 | 272 |
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER | JJQ | 1998-02-06 | 24 |
| K971586 | DIGENE CERVICAL BRUSH | HHT | 1997-09-19 | 141 |
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2004-05-28.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Digene Diagnostics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Digene Corp.?
FDA lists 9 510(k) clearances under the applicant name “Digene Corp.” (first 1997, latest 2001), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Digene Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Digene Corp. is 183 days.
Which FDA product codes appear under Digene Corp.?
The most frequent FDA product codes under this applicant name are LSK (Dna-Reagents, Chlamydia, 3); LSL (Dna-Reagents, Neisseria, 3); HHT (Spatula, Cervical, Cytological, 1).
Next steps
- See all 9 Digene Corp. clearances with predicates and recalls
- Run predicate analysis for product code LSK, Digene Corp.'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.