PMA P000021S041
- Device
- Dimension Vista TPSA Flex reagent cartridge (K6451)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S041
- Product code
- LTJ
- Decision date
- 2019-06-26
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- Add an alternate supplier to manufacture resin used in the production of Dimension Vista® Chemibead and Sensibead reagents.
Current openFDA PMA Record#
- Device
- Dimension Vista TPSA Flex reagent cartridge (K6451)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S041
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2019-06-26
- Decision code
- OK30
- Date received
- 2019-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier to manufacture resin used in the production of Dimension Vista® Chemibead and Sensibead reagents.