PMA P000027S031
- Device
- Elecsys free PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S031
- Product code
- LTJ
- Decision date
- 2018-06-13
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series
Current openFDA PMA Record#
- Device
- Elecsys free PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S031
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2018-06-13
- Decision code
- APPR
- Date received
- 2018-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series