PMA P000021S031
- Device
- Dimension TPSA Flex reagent cartridge (RF451)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S031
- Product code
- LTJ
- Decision date
- 2017-05-22
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- Transfer to a contract service provider for Dimension® RxL/RxL Max® and Dimension® Xpand/Xpand Plus Clinical Chemistry Systems Service Spare Parts.
Current openFDA PMA Record#
- Device
- Dimension TPSA Flex reagent cartridge (RF451)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S031
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2017-05-22
- Decision code
- OK30
- Date received
- 2017-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer to a contract service provider for Dimension® RxL/RxL Max® and Dimension® Xpand/Xpand Plus Clinical Chemistry Systems Service Spare Parts.