PMA P990055S004
- Device
- ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S004
- Product code
- NAF
- Decision date
- 2002-07-19
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- APPROVAL FOR THE ADJUSTMENT OF THE CALIBRATION OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S004
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2002-07-19
- Decision code
- APPR
- Date received
- 2002-03-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADJUSTMENT OF THE CALIBRATION OF THE DEVICE.