MMW · Class II · 21 CFR 866.6010

FDA Product Code MMW: System, Test, Tumor Marker, Monitoring, Bladder

Leading manufacturers include Bard Diagnostic Sciences,Inc., Vysis and Perimmune, Inc..

9
Total
9
Cleared
251d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Test, Tumor Marker, Monitoring, Bladder Devices (Product Code MMW)

9 devices
1–9 of 9
Cleared May 04, 2023
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
K203245
Nucleix , Ltd.
Medical Genetics · 912d
Cleared Jul 30, 2002
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
K021231
Matritech, Inc.
Immunology · 103d
Cleared Feb 08, 2002
UROVYSION BLADDER CANCER RECURRENCE KIT
K013785
Vysis
Immunology · 86d
Cleared Aug 03, 2001
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
K011031
Vysis
Immunology · 120d
Cleared Dec 08, 1998
BTA STAT TEST PRESCRIPTION HOME USE
K974845
Bard Diagnostic Sciences,Inc.
Immunology · 355d
Cleared Apr 15, 1998
BARD BTA TRAK TEST
K971402
Bard Diagnostic Sciences,Inc.
Immunology · 365d
Cleared Apr 30, 1997
AURA TEK FDP
K970353
Perimmune, Inc.
Immunology · 90d
Cleared Apr 16, 1997
BARD AND BTA TEST
K964151
Bard Diagnostic Sciences,Inc.
Immunology · 197d

About Product Code MMW - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code MMW since 1997, with 9 receiving FDA clearance (average review time: 251 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.