Dimension TPSA Flex reagent cartridge
FDA premarket approval P000021/S040 · decided 2019-06-20
Approval details
- PMA number
- P000021
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2019-05-13
- Decision date
- 2019-06-20
- Days to decision
- 38 days
- Decision code
- OK30
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Addition of an alternate supplier for the source lamp that is used in the manufacture of the Dimension family of instruments for use with the Dimension® TPSA Flex® reagent cartridge and Dimension® FPSA Flex® reagent cartridge
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