FREND Vitamin D Test System— 510(k) K162754

Name: FDA 510(k) clearance K162754
Creator: U.S. Food and Drug Administration
Published: 2017-01-12

Substantially Equivalent

Nanoentek USA, Inc.

FDA 510(k) clearance K162754 for FREND Vitamin D Test System, Substantially Equivalent on 2017-01-12. Applicant: Nanoentek USA, Inc.. Device class: 2.

Clearance details

Applicant: Nanoentek USA, Inc.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2016-09-30
Decision date: 2017-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.