Atellica IM Alpha Fetoprotein (AFP) Assay
FDA premarket approval P930036/S011 · decided 2019-03-08
Approval details
- PMA number
- P930036
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Atellica IM Alpha Fetoprotein (AFP) Assay
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2019-02-01
- Decision date
- 2019-03-08
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Adding an additional manufacturing site for the instrument module.
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