DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S021 · decided 2014-09-25
Approval details
- PMA number
- P020027
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2014-08-27
- Decision date
- 2014-09-25
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- ADDITION OF AN ALTERNATE AUTOMATED COLUMN (INTERCHIM PURIFLASH® PURIFICATION SYSTEM) PURIFICATION PROCEDURE TO THE EXISTING MANUAL COLUMN CHROMATOGRAPHY PURIFICATION PROCEDURE IN THE EUROPIUM PARTICLE RAW MATERIAL (EPRM) MANUFACTURING PROCESS.
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