PMA P990045S027
- Device
- ETI-AB-COREK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S027
- Decision date
- 2019-09-27
- Approval order statement
- Chromatography column cleaning procedure modifications.
Current openFDA PMA Record#
- Device
- ETI-AB-COREK PLUS assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S027
- Decision date
- 2019-09-27
- Decision code
- OK30
- Date received
- 2019-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Chromatography column cleaning procedure modifications.