PMA P010007

Device: IMMULITE Systems AFP
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P010007
Supplement: S017
Product code: LOK
Decision date: 2026-08-20
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.

Current openFDA PMA Record#

Device: IMMULITE Systems AFP
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P010007
Supplement: S027
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2026-08-20
Decision code: OK30
Date received: 2026-07-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.