ADVIA CENTAUR ANTI-HBS ASSAY
FDA premarket approval P030029/S012 · decided 2011-03-14
Approval details
- PMA number
- P030029
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR ANTI-HBS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2011-02-16
- Decision date
- 2011-03-14
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- CHANGE OF RAW MATERIAL USED IN THE PRODUCTION OF THE LITE REAGENT BUFFER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.