Cleared Traditional

IMMULITE? 2000 BR-MA

K233946 · Siemens Healthcare Diagnostics Products, Ltd. · Immunology

Mar 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K233946 is an FDA 510(k) clearance for the IMMULITE? 2000 BR-MA, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Siemens Healthcare Diagnostics Products, Ltd. (Llanberis, GB). The FDA issued a Cleared decision on March 13, 2024, 90 days after receiving the submission on December 14, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K233946 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2023
Decision Date	March 13, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF