IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA
FDA premarket approval P060005/S016 · decided 2022-10-14
Approval details
- PMA number
- P060005
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE® /IMMULITE® 1000 Free PSA and 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
- 2022-09-15
- Decision date
- 2022-10-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- Change in material composition of the glass bulb used in PMT (Photo Multiplier Tube) Assembly on the IMMULITE Family of Instruments.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.