ADVIA CENTAUR HBSAG
FDA premarket approval P030049/S003 · decided 2009-03-04
Approval details
- PMA number
- P030049
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR HBSAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-02-04
- Decision date
- 2009-03-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- CHANGE INVOLVING THE MANUFACTURING OF (BIOTINLATED) ANTIBODY AND ANTIGEN.
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