ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS
FDA premarket approval P030029/S001 · decided 2007-08-02
Approval details
- PMA number
- P030029
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2007-03-14
- Decision date
- 2007-08-02
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR AN ADDITIONAL COMPONENT SUPPLIER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.