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MMW — System, Test, Tumor Marker, Monitoring, Bladder Class II

FDA Device Classification

Classification Details

Product Code
MMW
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203245nucleixBladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NXMay 4, 2023
K033982vysisMODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTJanuary 22, 2004
K021231matritechNMP22 BLADDERCHEK KIT, NMP22 CONTROL KITJuly 30, 2002
K013785vysisUROVYSION BLADDER CANCER RECURRENCE KITFebruary 8, 2002
K011031vysisVYSIS UROVYSION BLADDER CANCER RECURRENCE KITAugust 3, 2001
K974845bard diagnostic sciencesBTA STAT TEST PRESCRIPTION HOME USEDecember 8, 1998
K971402bard diagnostic sciencesBARD BTA TRAK TESTApril 15, 1998
K970353perimmuneAURA TEK FDPApril 30, 1997
K964151bard diagnostic sciencesBARD AND BTA TESTApril 16, 1997