ARCHITECT CORE
FDA premarket approval P080023/S004 · decided 2011-01-14
Approval details
- PMA number
- P080023
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT CORE
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2010-12-22
- Decision date
- 2011-01-14
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
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