PMA P930036S011
- Device
- Atellica IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S011
- Product code
- LOK
- Decision date
- 2019-03-08
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Adding an additional manufacturing site for the instrument module.
Current openFDA PMA Record#
- Device
- Atellica IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S011
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional manufacturing site for the instrument module.