Copan Diagnostics Inc
FDA Regulatory Profile
Copan Diagnostics Inc appears in FDA public data with 1 recall, 10 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2620-2023, Class II) was initiated on July 14, 2023. Its most recent 510(k) clearance was granted on June 23, 2006.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2620-2023 | Class II | COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs. | July 14, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K061301 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | June 23, 2006 |
| K042970 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM | December 7, 2004 |
| K001780 | COPAN VIRAL TRANSYSTEM | July 31, 2001 |
| K993161 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | November 9, 1999 |
| K946287 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | March 10, 1995 |
| K946285 | COPAN VENTURI TRANSYSTEM STUARTS MEDIUM | March 10, 1995 |
| K946283 | COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM | March 10, 1995 |
| K946288 | COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM | March 10, 1995 |
| K946284 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | March 10, 1995 |
| K946286 | COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM | March 10, 1995 |