IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
FDA premarket approval P060005/S003 · decided 2010-01-21
Approval details
- PMA number
- P060005
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- Date received
- 2009-11-02
- Decision date
- 2010-01-21
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS IN NEWARK, DELAWARE.
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