ARCHITECT HBSAG AND HBSAG CONFIRMATORY
FDA premarket approval P060007/S001 · decided 2006-10-18
Approval details
- PMA number
- P060007
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT HBSAG AND HBSAG CONFIRMATORY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2006-09-22
- Decision date
- 2006-10-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- ADDITION OF SPECIFICATIONS, THE MODIFICATION OF SPECIFICATIONS, AND ADDITIONAL TESTING DURING THE MANUFACTURING PROCESS.
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