- Device
- IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S016
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2022-10-14
- Decision code
- OK30
- Date received
- 2022-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in material composition of the glass bulb used in PMT (Photo Multiplier Tube) Assembly on the IMMULITE Family of Instruments.