Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Copan ItaliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Copan Diagnostics Inc. with 10 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 14, 2023: COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 14, 2023 | COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.Class II · Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance | Device recalls |
| Jun 23, 2006 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMK061301 · JTW | 510(k) clearances |
| Dec 7, 2004 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMK042970 · JSM | 510(k) clearances |
| Jul 31, 2001 | COPAN VIRAL TRANSYSTEMK001780 · JSM | 510(k) clearances |
| Nov 9, 1999 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMK993161 · JTW | 510(k) clearances |
| Mar 10, 1995 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALK946284 · JSM | 510(k) clearances |
| Mar 10, 1995 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALK946287 · JSM | 510(k) clearances |
| Mar 10, 1995 | COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUMK946286 · JSM | 510(k) clearances |
| Mar 10, 1995 | COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMK946288 · JSM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
