Product code MMW— Immunology
AURA TEK FDP
- Classification name
- System, Test, Tumor Marker, Monitoring, Bladder
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code MMW
FDA has cleared devices under product code MMW between 1997 and 2023, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2004
- 2002
- 2001
- 1998
- 1997
Top applicants under product code MMW
Recent clearances under product code MMW
- K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
- K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
- K021231 — NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
- K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT
- K011031 — VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
- K974845 — BTA STAT TEST PRESCRIPTION HOME USE
- K971402 — BARD BTA TRAK TEST
- K970353 — AURA TEK FDP
- K964151 — BARD AND BTA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.