DIMENSION PSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S001 · decided 2001-07-31
Approval details
- PMA number
- P000021
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIMENSION PSA FLEX REAGENT CARTRIDGE
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2001-07-12
- Decision date
- 2001-07-31
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE ADDITION OF THE DIMENSION(R) PSA FLEX(R) REAGENT CARTRIDGE FOR USE WITH THE DIMENSION(R) XPAND(TM) 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.