PMA P060005S007
- Device
- FPSA IMMULITE SUBSTRATE REAGENT
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S007
- Product code
- MTG
- Decision date
- 2012-04-05
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
Current openFDA PMA Record#
- Device
- FPSA IMMULITE SUBSTRATE REAGENT
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S007
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2012-04-05
- Decision code
- APPR
- Date received
- 2011-12-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.