PMA P000021S001
- Device
- DIMENSION PSA FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S001
- Product code
- LTJ
- Decision date
- 2001-07-31
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE DIMENSION(R) PSA FLEX(R) REAGENT CARTRIDGE FOR USE WITH THE DIMENSION(R) XPAND(TM) SYSTEM.
Current openFDA PMA Record#
- Device
- DIMENSION PSA FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S001
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2001-07-31
- Decision code
- APPR
- Date received
- 2001-07-12
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE DIMENSION(R) PSA FLEX(R) REAGENT CARTRIDGE FOR USE WITH THE DIMENSION(R) XPAND(TM) SYSTEM.