PMA P020027S036
- Device
- Dimension Vista TPSA Flex reagent cartridge (K6452)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P020027
- Supplement
- S036
- Product code
- MTG
- Decision date
- 2019-06-26
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- 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 (K6452)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P020027
- Supplement
- S036
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- 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.