PMA P990055S003
- Device
- COMPLEXED PSA MICROTITER ELISA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S003
- Product code
- NAF
- Decision date
- 2002-03-13
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- COMPLEXED PSA MICROTITER ELISA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S003
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2002-03-13
- Decision code
- APPR
- Date received
- 2001-09-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.