FREND Vitamin D Test System

FDA 510(k) K162754 · Nanoentek USA, Inc.

Substantially Equivalent

510(k) numberK162754

Submission

Device name
FREND Vitamin D Test System
Applicant
Nanoentek USA, Inc.
Pleasanton, CA, US
Received
September 30, 2016
Decision date
January 12, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRG – System, Test, Vitamin D
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1825
Specialty
Clinical Chemistry

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Questions and answers

When was FREND Vitamin D Test System cleared by the FDA?

FREND Vitamin D Test System (K162754) received a 510(k) decision of Substantially Equivalent on January 12, 2017, 104 days after the submission was received.

What is the product code of K162754?

The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.