Atellica® IM Hepatitis B core IgM (aHBcM) Assay
FDA premarket approval P030040/S021 · decided 2022-03-29
Approval details
- PMA number
- P030040
- Supplement
- S021
- 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
- 2022-03-22
- Decision date
- 2022-03-29
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Manufacture an instrument component at another location.
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