Atellica IM Hepatitis B e Antigen (HBeAg) Assay
FDA premarket approval P090024/S008 · decided 2020-04-03
Approval details
- PMA number
- P090024
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Atellica IM Hepatitis B e Antigen (HBeAg) Assay
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2020-03-09
- Decision date
- 2020-04-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.