DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S016 · decided 2010-04-26
Approval details
- PMA number
- P000021
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2010-03-25
- Decision date
- 2010-04-26
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- REPLACEMENT OF THE INSULIN SUPPLY USED IN THE ANTIBODY GROWTH MEDIA PRODUCTION PROCESS TO COMPENSATE FOR A SHORTAGE.
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