PMA P990042S003
- Device
- DIASORIN ETI-AB-AUK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2002-06-24
- 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 OF THE POST-APPROVAL STUDY FOR THE DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE MARCH 30, 2001 APPROVAL ORDER FOR P990042.
Current openFDA PMA Record#
- Device
- DIASORIN ETI-AB-AUK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2002-06-24
- Decision code
- APPR
- Date received
- 2002-04-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE MARCH 30, 2001 APPROVAL ORDER FOR P990042.