Dimension Vista TPSA Flex reagent cartridge (K6451)
FDA premarket approval P000021/S035 · decided 2017-12-15
Approval details
- PMA number
- P000021
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dimension Vista TPSA Flex reagent cartridge (K6451)
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2017-11-20
- Decision date
- 2017-12-15
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Transfer a contract service provider to manufacture subassembly components and service spare parts, which are used in the Dimension Vista® System manufacturing process.
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