DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S014 · decided 2009-06-04
Approval details
- PMA number
- P000021
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-04-06
- Decision date
- 2009-06-04
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE USE OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEMS (AMAS) (ADVIA LABCELL AND ADVIA WORKCELL).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.