Cleared Traditional

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry

Apr 2024

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K232587 is an FDA 510(k) clearance for the MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 12, 2024, 231 days after receiving the submission on August 25, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number	K232587 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	April 12, 2024
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF