Dimension Vista TPSA Flex reagent cartridge
FDA premarket approval P000021/S039 · decided 2018-12-27
Approval details
- PMA number
- P000021
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Dimension Vista TPSA Flex reagent cartridge
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2018-09-28
- Decision date
- 2018-12-27
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Approval for labeling changes describing the impact of endogenous biotin.
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