ARCHITECT CORE
FDA premarket approval P080023/S026 · decided 2014-12-11
Approval details
- PMA number
- P080023
- Supplement
- S026
- Supplement type
- 30-Day Notice
- 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
- 2014-11-13
- Decision date
- 2014-12-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
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