IMMULITE 2000 HBsAg Confirmatory
FDA premarket approval P010050/S018 · decided 2020-09-08
Approval details
- PMA number
- P010050
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE 2000 HBsAg Confirmatory
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2020-08-12
- Decision date
- 2020-09-08
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- Remove select inspection criteria from the raw materials used to manufacture IMMULITE Substrate Reagent.
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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 |