IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA
FDA premarket approval P930027/S017 · decided 2017-03-21
Approval details
- PMA number
- P930027
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2016-08-17
- Decision date
- 2017-03-21
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for a change to quality control testing procedure to reduce the number of dilution levels of WHO 96/670 used in the value assignment of the PSA Release panel and remove requirement to value assign the Male normal panel against WHO 96/670.
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