PMA P990045S028
- Device
- ETI-AB-COREK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S028
- Decision date
- 2020-08-13
- Approval order statement
- Manufacturing process changes.
Current openFDA PMA Record#
- Device
- ETI-AB-COREK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S028
- Decision date
- 2020-08-13
- Decision code
- OK30
- Date received
- 2020-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process changes.