PMA P950021S005
- Device
- TOTAL PSA MICROTITER ELISA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S005
- Product code
- LTJ
- Decision date
- 2002-03-13
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- TOTAL PSA MICROTITER ELISA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S005
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- 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.