DIASORIN ETI-AB-AUK PLUS ASSAY
FDA premarket approval P990042/S003 · decided 2002-06-24
Approval details
- PMA number
- P990042
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- DIASORIN ETI-AB-AUK PLUS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2002-04-04
- Decision date
- 2002-06-24
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- 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.
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