PMA P990045S024
- Device
- ETI-AB-COREK PLUS Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S024
- Decision date
- 2018-04-24
- Approval order statement
- Improve the process for cleaning critical manufacturing parts and equipment.
Current openFDA PMA Record#
- Device
- ETI-AB-COREK PLUS Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S024
- Decision date
- 2018-04-24
- Decision code
- OK30
- Date received
- 2018-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Improve the process for cleaning critical manufacturing parts and equipment.