IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT
FDA premarket approval P930027/S016 · decided 2014-12-02
Approval details
- PMA number
- P930027
- Supplement
- S016
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2014-07-23
- Decision date
- 2014-12-02
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- APPROVAL FOR AN ADDITIONAL ASSESSMENT METHOD BY UTILIZING A PANEL OF 10 NORMAL MALE SERA AND A RELEASE PANEL OF PATIENT POOLS TO MAINTAIN THE PERFORMANCE OF THE DEVICE ALIGNED TO THE WHO STANDARD 96/670.
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