ETI-MAX 3000 ANALYZER
FDA premarket approval P990042/S008 · decided 2011-01-14
Approval details
- PMA number
- P990042
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ETI-MAX 3000 ANALYZER
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2008-12-22
- Decision date
- 2011-01-14
- Days to decision
- 753 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR THE ETI-AB-AUK PLUS ASSAY ON THE ETI-MAX 3000 ANALYZER.
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