IMMULITE 2000/2000 XPi Anti-HBc IgM
FDA premarket approval P010053/S013 · decided 2021-03-11
Approval details
- PMA number
- P010053
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMMULITE 2000/2000 XPi Anti-HBc IgM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2020-12-22
- Decision date
- 2021-03-11
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- Approved for labeling changes as a result of biotin interference testing.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (K213510) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 |
| IMMULITE® 2000 Cortisol (K202826) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| IMMULITE/IMMULITE® 1000 Cortisol (K203270) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |