Dimension FPSA Flex reagent cartridge
FDA premarket approval P020027/S035 · decided 2019-06-20
Approval details
- PMA number
- P020027
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dimension FPSA Flex reagent cartridge
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2019-05-13
- Decision date
- 2019-06-20
- Days to decision
- 38 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Addition of an alternate supplier for the source lamp that is used in the manufacture of the Dimension family of instruments for use with the Dimension® TPSA Flex® reagent cartridge and Dimension® FPSA Flex® reagent cartridge
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.