PMA P010007S023

Device: IMMULITE 2000 Alpha-Fetoprotein (AFP)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P010007
Supplement: S023
Product code: LOK
Decision date: 2025-04-11
Classification: Immunology
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site

Current openFDA PMA Record#

Device: IMMULITE 2000 Alpha-Fetoprotein (AFP)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P010007
Supplement: S023
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2025-04-11
Decision code: OK30
Date received: 2025-03-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site