PMA P930027S021
- Device
- IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S021
- Product code
- MTF
- Decision date
- 2019-07-11
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Approval for a change to the product quality control (QC) method in order to enhance the safety of IMMULITE® Third Generation PSA High Adjustor (LUPH), IMMULITE® Systems PSA High Adjustor (LPSH) and IMMULITE® 2000 Systems PSA High Adjustor (LPSH)
Current openFDA PMA Record#
- Device
- IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S021
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2019-07-11
- Decision code
- APPR
- Date received
- 2019-06-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the product quality control (QC) method in order to enhance the safety of IMMULITE® Third Generation PSA High Adjustor (LUPH), IMMULITE® Systems PSA High Adjustor (LPSH) and IMMULITE® 2000 Systems PSA High Adjustor (LPSH)