Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory
FDA premarket approval P110041/S017 · decided 2025-10-17
Approval details
- PMA number
- P110041
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Corp.
- Date received
- 2025-08-04
- Decision date
- 2025-10-17
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the Atellica CI Analyzer with Atellica Sample Handler configuration for Atellica IM HBcT2, aHBs2, HBeAg, aHBcM, aHBe2, HBsII & HBsII Conf assays.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (K103360) | Siemens Corp. | 2010-12-17 |
| KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY (K993947) | Siemens Corp. | 1999-12-21 |
| AX WORKSTATION DR-VIEWER SOFTWARE OPTION (K992925) | Siemens Corp. | 1999-11-23 |
| HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM (K991652) | Siemens Corp. | 1999-08-03 |
| SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION (K991600) | Siemens Corp. | 1999-06-09 |
| FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR (K984221) | Siemens Corp. | 1999-02-12 |
| PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS (K984224) | Siemens Corp. | 1999-02-02 |
| PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE (K982536) | Siemens Corp. | 1998-11-24 |