ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
FDA premarket approval P060007/S002 · decided 2009-07-13
Approval details
- PMA number
- P060007
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2009-01-30
- Decision date
- 2009-07-13
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/I2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.
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