ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
FDA premarket approval P060035/S001 · decided 2009-06-23
Approval details
- PMA number
- P060035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2009-01-08
- Decision date
- 2009-06-23
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MIGRATION OF THE ARCHITECT CORE-M ASSAY TO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
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