PMA P990038S002
- Device
- ETI-MAK-2 PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S002
- Product code
- LOM
- Decision date
- 2002-03-07
- 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 INCLUSION OF THE INSTRUMENT REPRODUCIBILITY STUDY IN THE PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- ETI-MAK-2 PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S002
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2002-03-07
- Decision code
- APPR
- Date received
- 2002-01-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR INCLUSION OF THE INSTRUMENT REPRODUCIBILITY STUDY IN THE PACKAGE INSERT.