Cleared Traditional

Elecsys Vitamin D total III

K210901 · Roche Diagnostics · Chemistry
Sep 2021
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K210901 is an FDA 510(k) clearance for the Elecsys Vitamin D total III, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on September 1, 2021, 159 days after receiving the submission on March 26, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K210901 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2021
Decision Date September 01, 2021
Days to Decision 159 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
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
BioPlex 2200 25-OH Vitamin D Kit
K180577 · Bio-Rad Laboratories · Jun 2018