Copan Diagnostics Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2620-2023Class IICOPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.July 14, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMJune 23, 2006
K042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMDecember 7, 2004
K001780COPAN VIRAL TRANSYSTEMJuly 31, 2001
K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMNovember 9, 1999
K946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMMarch 10, 1995
K946284COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALMarch 10, 1995
K946285COPAN VENTURI TRANSYSTEM STUARTS MEDIUMMarch 10, 1995
K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMMarch 10, 1995
K946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALMarch 10, 1995
K946286COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUMMarch 10, 1995