- Device
- Elecsys free PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S036
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2021-11-16
- Decision code
- OK30
- Date received
- 2021-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of manufacturing activities for the production of lyophilized calibrators to an additional building within the same manufacturing site.