FPSA IMMULITE SUBSTRATE REAGENT
FDA premarket approval P060005/S007 · decided 2012-04-05
Approval details
- PMA number
- P060005
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FPSA IMMULITE SUBSTRATE REAGENT
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- Date received
- 2011-12-19
- Decision date
- 2012-04-05
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
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