PMA P940035S004
- Device
- NMP22 BLADDERCHEK TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S004
- Product code
- NAH
- Decision date
- 2008-05-20
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BINAX, INC., SCARBOROUGH, MAINE.
Current openFDA PMA Record#
- Device
- NMP22 BLADDERCHEK TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S004
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2008-05-20
- Decision code
- APPR
- Date received
- 2008-03-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BINAX, INC., SCARBOROUGH, MAINE.