FDA 510(k) Applications for Medical Device Product Code "JTW"
(System, Transport, Aerobic)

FDA 510(k) Number Applicant Device Name Decision Date
K993161 COPAN DIAGNOSTICS, INC. COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM 11/09/1999
K061301 COPAN DIAGNOSTICS, INC. COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM 06/23/2006
K121039 COPAN FLOCK TECHNOLOGIES COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM 05/25/2012
K961148 DIFCO LABORATORIES, INC. CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) 04/26/1996
K022874 GEN-PROBE, INC. GEN-PROBE APTIMA COMBO 2 ASSAY 09/17/2002
K013819 SIERRA DIAGNOSTIC, L.L.C. URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM 02/28/2002
K983244 TREK DIAGNOSTIC SYSTEMS, INC. SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) 11/30/1998


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