Atellica IM HBc Total 2 (HBcT2)
FDA premarket approval P210019/S003 · decided 2024-07-22
Approval details
- PMA number
- P210019
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM HBc Total 2 (HBcT2)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2024-01-24
- Decision date
- 2024-07-22
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the migration of the ADVIA Centaur HBcT2 assay (P210019), from the ADVIA Centaur XP to the Atellica CI analyzer, which will be known as the Atellica IM HBcT2 assay.
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|---|---|---|
| Atellica CH Acetaminophen 2 (ACTM) (K261364) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 |
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