ETI-AB-AUK PLUS
FDA premarket approval P990042/S006 · decided 2003-06-30
Approval details
- PMA number
- P990042
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ETI-AB-AUK PLUS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2003-04-07
- Decision date
- 2003-06-30
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR INCLUSION OF POST-APPROVAL STUDY RESULTS IN THE PACKAGE INSERT.
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