PMA P000027S012
- Device
- ELECSYS FREE PSA (FPSA) TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S012
- Product code
- MTG
- Decision date
- 2012-02-24
- 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 EXTENSION OF THE ELECSYS FREE PSA (FPSA) TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.
Current openFDA PMA Record#
- Device
- ELECSYS FREE PSA (FPSA) TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S012
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2012-02-24
- Decision code
- APPR
- Date received
- 2011-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXTENSION OF THE ELECSYS FREE PSA (FPSA) TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.