DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S021 · decided 2011-12-15
Approval details
- PMA number
- P000021
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2011-11-22
- Decision date
- 2011-12-15
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- CHANGE IN SUPPLIER FOR DEXTRAN T500 USED IN PRODUCTION OF FLEX REAGENT CARTRIDGES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.