ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY
FDA premarket approval P060007/S020 · decided 2012-09-14
Approval details
- PMA number
- P060007
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2012-08-17
- Decision date
- 2012-09-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG
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