ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
FDA premarket approval P060007/S009 · decided 2011-03-30
Approval details
- PMA number
- P060007
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Trade name
- ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2011-03-01
- Decision date
- 2011-03-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- TEST METHOD CONVERSIONS FOR CALF BOVINE SERUM FOR THE TWO HBSAG ASSAYS.
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