DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S015 · decided 2010-05-27
Approval details
- PMA number
- P000021
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-05-19
- Decision date
- 2010-05-27
- Days to decision
- 373 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION EXL WITH LM SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.