Atellica IM Hepatitis B core IgM (aHBcM) Assay
FDA premarket approval P030040/S020 · decided 2021-04-27
Approval details
- PMA number
- P030040
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Atellica IM Hepatitis B core IgM (aHBcM) Assay
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2021-04-01
- Decision date
- 2021-04-27
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Moving manufacturing of Atellica IM analyzers component/subassembly named Autoloader to an internal supplier.
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