PMA P990044S020
- Device
- ETI-CORE-IGMK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S020
- Decision date
- 2017-05-23
- Approval order statement
- Change to temperature and cycle parameters on instruments used to manufacture kit subcomponents.
Current openFDA PMA Record#
- Device
- ETI-CORE-IGMK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S020
- Decision date
- 2017-05-23
- Decision code
- OK30
- Date received
- 2017-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to temperature and cycle parameters on instruments used to manufacture kit subcomponents.