- Device
- NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S017
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2022-07-12
- Decision code
- APPR
- Date received
- 2022-02-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to manufacture Alere NMP22 BladderChek Test under Abbott Diagnostics Scarborough, Inc.s new brand name: NMP22 BladderChek Test.