SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS
FDA premarket approval P930027/S008 · decided 2010-02-25
Approval details
- PMA number
- P930027
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2008-12-16
- Decision date
- 2010-02-25
- Days to decision
- 436 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- APPROVAL FOR IMMULITE 1000/2000/2500 PSA AND IMMULITE 1000/2000/2500 THIRD GENERATION PSA TO ADD AN ADDITIONAL ANTIBODY (MURINE MONOCLONAL ANTIBODY CONJUGATE: MAB 7F4), INCLUDE A PH TREATMENT TO THE CHICKEN SERUM AND REMOVAL OF THIMERASOL AS A PRESERVATIVE.
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