Dimension® TPSA Flex® reagent cartridge
FDA premarket approval P000021/S045 · decided 2023-09-26
Approval details
- PMA number
- P000021
- Supplement
- S045
- 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
- 2023-08-29
- Decision date
- 2023-09-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Addition of alternate optical filters for 405nm and 452nm wavelengths used in Photometer Assembly on the Dimension Family of Instruments.
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