PMA P000021S008
- Device
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S008
- Product code
- LTJ
- Decision date
- 2005-07-11
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- CHANGE TO PREVENT LOSS OF REAGENT DUE TO MICROBIAL CONTAMINATION.
Current openFDA PMA Record#
- Device
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S008
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2005-07-11
- Decision code
- OK30
- Date received
- 2005-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO PREVENT LOSS OF REAGENT DUE TO MICROBIAL CONTAMINATION.