PMA P010007

Device: IMMULITE 2000 AFP
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P010007
Supplement: S017
Product code: LOK
Decision date: 2026-07-27
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval of the change to in-process manufacturing quality testing for the IMMULITE 2000 XPi analyzers and IMMULITE 2000 / IMMULITE 2000 XPi spare probe assemblies.

Current openFDA PMA Record#

Device: IMMULITE 2000 AFP
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P010007
Supplement: S026
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2026-07-27
Decision code: OK30
Date received: 2026-06-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the change to in-process manufacturing quality testing for the IMMULITE 2000 XPi analyzers and IMMULITE 2000 / IMMULITE 2000 XPi spare probe assemblies.