IMMULITE 2000 Free PSA
FDA premarket approval P060005/S010 · decided 2019-12-19
Approval details
- PMA number
- P060005
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 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
- 2019-11-25
- Decision date
- 2019-12-19
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- Modify the resin used in manufacture of reaction tubes.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.