PMA P990045S019
- Device
- DiaSorin ETI-AB-COREK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S019
- Decision date
- 2017-05-25
- Approval order statement
- Change to a test method for incoming material.
Current openFDA PMA Record#
- Device
- DiaSorin ETI-AB-COREK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S019
- Decision date
- 2017-05-25
- Decision code
- OK30
- Date received
- 2017-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a test method for incoming material.