IMMULITE® 2000 BR-MA— 510(k) K233946

Name: FDA 510(k) clearance K233946
Creator: U.S. Food and Drug Administration
Published: 2024-03-13

Substantially Equivalent

Siemens Healthcare Diagnostics Products, Ltd.

FDA 510(k) clearance K233946 for IMMULITE® 2000 BR-MA, Substantially Equivalent on 2024-03-13. Applicant: Siemens Healthcare Diagnostics Products, Ltd.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Products, Ltd.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2023-12-14
Decision date: 2024-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanberis, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.