PMA P910065S006
- Device
- AIA-PACK PA PSA, ST AIA-PACK PA PSA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S006
- Product code
- LTJ
- Decision date
- 2005-11-30
- 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 CHANGES IN THE MANUFACTURING PROCESS OF THE MONOCLONAL ANTIBODIES USED IN THE PRODUCTION OF THE ASSAYS AND CHANGE IN THE MANUFACTURING FACILITY USED FOR THE ABOVE MANUFACTURING PROCESS FROM NISSEIKEN CO., LTD., TOKYO, JAPAN TO TOSOH AIA, INC. IN TOYAMA, JAPAN.
Current openFDA PMA Record#
- Device
- AIA-PACK PA PSA, ST AIA-PACK PA PSA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S006
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2005-11-30
- Decision code
- APPR
- Date received
- 2005-06-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS OF THE MONOCLONAL ANTIBODIES USED IN THE PRODUCTION OF THE ASSAYS AND CHANGE IN THE MANUFACTURING FACILITY USED FOR THE ABOVE MANUFACTURING PROCESS FROM NISSEIKEN CO., LTD., TOKYO, JAPAN TO TOSOH AIA, INC. IN TOYAMA, JAPAN.