Cleared Traditional

MAGLUMI 2000 25-OH Vitamin D

K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry
Aug 2019
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K191499 is an FDA 510(k) clearance for the MAGLUMI 2000 25-OH Vitamin D, 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 August 1, 2019, 56 days after receiving the submission on June 6, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K191499 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2019
Decision Date August 01, 2019
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRG — System, Test, Vitamin D
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1825

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