PMA P060005S003
- Device
- IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S003
- Product code
- MTG
- Decision date
- 2010-01-21
- 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 MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS IN NEWARK, DELAWARE.
Current openFDA PMA Record#
- Device
- IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S003
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2010-01-21
- Decision code
- APPR
- Date received
- 2009-11-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS IN NEWARK, DELAWARE.