ARCHITECT HBSAG/CONFIMATORY
FDA premarket approval P060007/S014 · decided 2011-06-01
Approval details
- PMA number
- P060007
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT HBSAG/CONFIMATORY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2011-05-04
- Decision date
- 2011-06-01
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.
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