IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS
FDA premarket approval P010052/S012 · decided 2015-07-27
Approval details
- PMA number
- P010052
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date received
- 2014-11-28
- Decision date
- 2015-07-27
- Days to decision
- 241 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Llanberis
- Statement
- APPROVAL TO CHANGE THE MANUFACTURING PROCESS FOR THE CONJUGATE BULK SOLUTION.
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510(k) clearances by this applicant
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| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
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