PMA P930036S014

Device: Atellica IM Alpha Fetoprotien (AFP) Assay
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S014
Product code: LOK
Decision date: 2020-04-03
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).

Current openFDA PMA Record#

Device: Atellica IM Alpha Fetoprotien (AFP) Assay
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S014
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2020-04-03
Decision code: OK30
Date received: 2020-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).