ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY
FDA premarket approval P100039/S003 · decided 2015-07-10
Approval details
- PMA number
- P100039
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2015-06-11
- Decision date
- 2015-07-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
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