DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S027 · decided 2015-12-15
Approval details
- PMA number
- P000021
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-06-04
- Decision date
- 2015-12-15
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE MODIFIED PROCESS OF MANUFACTURING THEPOLYPROPYLENE RESIN USED IN THE PRODUCTION OF DIMENSION HM REACTION VESSELS AND THE VISTA LOCI REACTION VESSELS.
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