PMA P930036S017
- Device
- Atellica® IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S017
- Product code
- LOK
- Decision date
- 2021-08-25
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Changing primary reagent label to one common label for Atellica IM and ADVIA Centaur ReadyPacks.
Current openFDA PMA Record#
- Device
- Atellica® IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S017
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2021-08-25
- Decision code
- OK30
- Date received
- 2021-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changing primary reagent label to one common label for Atellica IM and ADVIA Centaur ReadyPacks.