PMA P990044S026
- Device
- ETI-CORE-IGMK Plus Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S026
- Decision date
- 2019-07-18
- Approval order statement
- Relocation of reagent manufacture from one room to another within the same establishment
Current openFDA PMA Record#
- Device
- ETI-CORE-IGMK Plus Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S026
- Decision date
- 2019-07-18
- Decision code
- OK30
- Date received
- 2019-06-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of reagent manufacture from one room to another within the same establishment