PMA P930027S019
- Device
- Immulite/Immulite 1000 PSA/Immulite 2000 PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S019
- Product code
- MTF
- Decision date
- 2018-04-16
- 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 an update to the Instructions for Use (IFU) High-Dose Hook Effect claim on IMMULITE / IMMULITE 1000 and IMMULITE 2000 platforms with values obtained for complex PSA (PSA-ACT) high dose effect.
Current openFDA PMA Record#
- Device
- Immulite/Immulite 1000 PSA/Immulite 2000 PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S019
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2018-04-16
- Decision code
- APPR
- Date received
- 2018-03-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the Instructions for Use (IFU) High-Dose Hook Effect claim on IMMULITE / IMMULITE 1000 and IMMULITE 2000 platforms with values obtained for complex PSA (PSA-ACT) high dose effect.