PMA P940035S016
- Device
- Alere NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S016
- Product code
- NAH
- Decision date
- 2021-06-15
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- New vendor for the resin contained in the nitrocellulose membrane.
Current openFDA PMA Record#
- Device
- Alere NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S016
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2021-06-15
- Decision code
- OK30
- Date received
- 2021-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New vendor for the resin contained in the nitrocellulose membrane.