PMA P000027S027
- Device
- Elecsys free PSA, free PSA CalSet, and free PSA CalCheck
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S027
- Product code
- MTG
- Decision date
- 2018-07-27
- 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 the migration of Elecsys free PSA, free PSA CalSet and free PSA CalCheck on the cobas e 801 immunoassay analyzer
Current openFDA PMA Record#
- Device
- Elecsys free PSA, free PSA CalSet, and free PSA CalCheck
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S027
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2018-07-27
- Decision code
- APPR
- Date received
- 2017-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the migration of Elecsys free PSA, free PSA CalSet and free PSA CalCheck on the cobas e 801 immunoassay analyzer