PMA P990038S018
- Device
- ETI-MAK-2 PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S018
- Product code
- LOM
- Decision date
- 2013-06-25
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
Current openFDA PMA Record#
- Device
- ETI-MAK-2 PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S018
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2013-06-25
- Decision code
- OK30
- Date received
- 2013-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.