PMA P930027S016
- Device
- IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S016
- Product code
- MTF
- Decision date
- 2014-12-02
- 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 ADDITIONAL ASSESSMENT METHOD BY UTILIZING A PANEL OF 10 NORMAL MALE SERA AND A RELEASE PANEL OF PATIENT POOLS TO MAINTAIN THE PERFORMANCE OF THE DEVICE ALIGNED TO THE WHO STANDARD 96/670.
Current openFDA PMA Record#
- Device
- IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S016
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2014-12-02
- Decision code
- APPR
- Date received
- 2014-07-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL ASSESSMENT METHOD BY UTILIZING A PANEL OF 10 NORMAL MALE SERA AND A RELEASE PANEL OF PATIENT POOLS TO MAINTAIN THE PERFORMANCE OF THE DEVICE ALIGNED TO THE WHO STANDARD 96/670.