Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)
FDA premarket approval P030040/S014 · decided 2018-08-24
Approval details
- PMA number
- P030040
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2018-08-15
- Decision date
- 2018-08-24
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for change of the proprietary names of Atellica IM Hepatitis B core Antigen (aHBcM) and Atellica IM Hepatitis B Core Antigen Quality Control (aHBcM QC) to Atellica IM Hepatitis B core lgM (aHBcM) assay and Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC).
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