PMA P940035S010
- Device
- ALERE NMP22 TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S010
- Product code
- NAH
- Decision date
- 2013-07-16
- 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 ADDITIONS TO THE LIMITATIONS AND PRECAUTIONS SECTIONS OF THE PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- ALERE NMP22 TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S010
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2013-07-16
- Decision code
- APPR
- Date received
- 2013-07-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITIONS TO THE LIMITATIONS AND PRECAUTIONS SECTIONS OF THE PACKAGE INSERT.