PMA P990043S013
- Device
- ETI-EBK PLUS KIT
- Applicant
- DiaSorin, Inc.
- PMA number
- P990043
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2010-05-21
- 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
- APPROVAL FOR CHANGING BSA RAW MATERIAL.
Current openFDA PMA Record#
- Device
- ETI-EBK PLUS KIT
- Applicant
- DiaSorin, Inc.
- PMA number
- P990043
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2010-05-21
- Decision code
- APPR
- Date received
- 2009-11-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR CHANGING BSA RAW MATERIAL.