PMA P990056S035
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S035
- Product code
- MTF
- Decision date
- 2019-04-24
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- 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 total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S035
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- 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