PMA P060005S004
- Device
- IMMULITE/IMMULITE 2000 FREE PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S004
- Product code
- MTG
- Decision date
- 2011-04-26
- 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 INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.
Current openFDA PMA Record#
- Device
- IMMULITE/IMMULITE 2000 FREE PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S004
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2011-04-26
- Decision code
- APPR
- Date received
- 2011-02-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.