PMA P940035S002
- Device
- MATRITECH NMP22 TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S002
- Product code
- NAH
- Decision date
- 2000-01-18
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- The device is used as an aid 1)in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off >= 7.5U/ml) in conjunction with and not in lieu of current standard diagnostic procedures and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off >10U/ml).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P940035S002B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- MATRITECH NMP22 TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S002
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2000-01-18
- Decision code
- APPR
- Date received
- 1999-07-23
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- The device is used as an aid 1)in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off >= 7.5U/ml) in conjunction with and not in lieu of current standard diagnostic procedures and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off >10U/ml).