Cleared Traditional

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

K153361 · Fujirebio Diagnostics,Inc. · Chemistry
Apr 2016
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K153361 is an FDA 510(k) clearance for the Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on April 15, 2016, 147 days after receiving the submission on November 20, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K153361 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2015
Decision Date April 15, 2016
Days to Decision 147 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

Similar Devices — MRG System, Test, Vitamin D

All 45
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Apr 2024
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · Immunostics Inc., · Sep 2023
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc. · Jan 2023
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021
ADVIA Centaur Vitamin D Total (VitD)
K200509 · Siemens Healthcare Diagnostics, Inc. · May 2020
MAGLUMI 2000 25-OH Vitamin D
K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Aug 2019