ADVIA ANTI-HBS ASSAY
FDA premarket approval P030029/S011 · decided 2010-10-18
Approval details
- PMA number
- P030029
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA ANTI-HBS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2010-09-29
- Decision date
- 2010-10-18
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- MANUFACTURING CHANGE TO ELIMINATE A QUALITY CONTROL TEST.
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