PMA P930027S018
- Device
- IMMULITE / IMMULITE 1000 Third Generation PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S018
- Product code
- MTF
- Decision date
- 2017-10-11
- 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 temporary changes to the product quality controls that enhances the safety of IMMULITE® 3rd Generation PSA High Adjustor (LUPH).
Current openFDA PMA Record#
- Device
- IMMULITE / IMMULITE 1000 Third Generation PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S018
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2017-10-11
- Decision code
- APPR
- Date received
- 2017-09-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for temporary changes to the product quality controls that enhances the safety of IMMULITE® 3rd Generation PSA High Adjustor (LUPH).