Copan Diagnostics, Inc.: FDA clearances and approvals
Copan Diagnostics, Inc. has 10 FDA 510(k) clearances (first 1995, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time: 73 days. openFDA lists 1 product recall by a recalling firm named Copan Diagnostics, Inc.
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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | 8 | 8 |
| JTW | System, Transport, Aerobic | 2 | 2 |
Review panels
- Microbiology (10)
Most recent Copan Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061301 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | JTW | 2006-06-23 | 44 |
| K042970 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM | JSM | 2004-12-07 | 40 |
| K001780 | COPAN VIRAL TRANSYSTEM | JSM | 2001-07-31 | 413 |
| K993161 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | JTW | 1999-11-09 | 48 |
| K946288 | COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM | JSM | 1995-03-10 | 73 |
| K946287 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | JSM | 1995-03-10 | 73 |
| K946286 | COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM | JSM | 1995-03-10 | 73 |
| K946285 | COPAN VENTURI TRANSYSTEM STUARTS MEDIUM | JSM | 1995-03-10 | 73 |
| K946284 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | JSM | 1995-03-10 | 73 |
| K946283 | COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM | JSM | 1995-03-10 | 73 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-07-14.
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 Copan Diagnostics, Inc. have?
Copan Diagnostics, Inc. has 10 FDA 510(k) clearances (first 1995, latest 2006), across 2 product codes in 1 review panel.
How long does FDA take to clear Copan Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Copan Diagnostics, Inc.'s cleared 510(k)s is 73 days.
What devices does Copan Diagnostics, Inc. make?
Its most frequent FDA product codes are JSM (Culture Media, Non-Propagating Transport, 8); JTW (System, Transport, Aerobic, 2).
Has Copan Diagnostics, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Copan Diagnostics, Inc; the most recent began 2023-07-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Copan Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSM, Copan Diagnostics, 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.