System, Test, Tumor Marker, Monitoring, Bladder
FDA product code MMW · 9 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.6010
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1997-04-16 – 2023-05-04
MMW
2023-05-04
MMW
2004-01-22
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
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MMW
2002-07-30
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
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MMW
2002-02-08
UROVYSION BLADDER CANCER RECURRENCE KIT
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MMW
2001-08-03
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
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MMW
1998-12-08
BTA STAT TEST PRESCRIPTION HOME USE
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MMW
1998-04-15
BARD BTA TRAK TEST
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MMW
1997-04-30
AURA TEK FDP
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MMW
1997-04-16
BARD AND BTA TEST
View details →No matching devices.
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