PMA P000027S033
- Device
- Elecsys free PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S033
- Product code
- MTG
- Decision date
- 2019-04-24
- 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 a manufacturing site for the cobas e 411 Analyzer located at Hitachi High-Technologies Corp., 1892-1, Oazategama, Omuta, Fukuoka, 836-0004 Japan
Current openFDA PMA Record#
- Device
- Elecsys free PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S033
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2019-04-24
- Decision code
- APPR
- Date received
- 2018-10-26
- 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 for the cobas e 411 Analyzer located at Hitachi High-Technologies Corp., 1892-1, Oazategama, Omuta, Fukuoka, 836-0004 Japan