Dimension TPSA Flex Reagent Cartridge
FDA premarket approval P000021/S033 · decided 2018-04-13
Approval details
- PMA number
- P000021
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dimension TPSA Flex Reagent Cartridge
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2017-09-25
- Decision date
- 2018-04-13
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Approval of the instrument manufacturing site change for the Dimension® EXL integrated systems to the Siemens instrument manufacturing facility located in Flanders, New Jersey.
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