← Product Code [MRG](/productcode/MRG) · K260674

# Atellica IM Vitamin D Total II (VitDII) (K260674)

_Siemens Healthcare Diagnostics, Inc. · MRG · Nov 6, 2026 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260674

## Device Facts

- **Applicant:** Siemens Healthcare Diagnostics, Inc.
- **Product Code:** [MRG](/productcode/MRG.md)
- **Decision Date:** Nov 6, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1825
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

## Special Controls

*Classification.* Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

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**Source:** [https://fda.innolitics.com/device/K260674](https://fda.innolitics.com/device/K260674)

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