PMA P000027S032
- Device
- Elecsys free PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S032
- Product code
- LTJ
- Decision date
- 2018-10-25
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- Addition of a raw material supplier.
Current openFDA PMA Record#
- Device
- Elecsys free PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S032
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2018-10-25
- Decision code
- OK30
- Date received
- 2018-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a raw material supplier.