Atellica IM Alpha Fetoprotein (AFP)
FDA premarket approval P930036/S009 · decided 2018-10-25
Approval details
- PMA number
- P930036
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Alpha Fetoprotein (AFP)
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2018-07-27
- Decision date
- 2018-10-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the placement of the PMA approved Siemens Atellica® IM Immunology assays on the Atellica Solution.
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