PMA P940035S006
- Device
- NMP22 BLADDERCHEK TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S006
- Product code
- NAH
- Decision date
- 2011-11-15
- 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 MANUFACTURING SITE LOCATED AT ALERE SCARBOROUGH, INC. IN SCARBOROUGH, MAINE.
Current openFDA PMA Record#
- Device
- NMP22 BLADDERCHEK TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S006
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2011-11-15
- Decision code
- APPR
- Date received
- 2011-05-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING SITE LOCATED AT ALERE SCARBOROUGH, INC. IN SCARBOROUGH, MAINE.