Spectrum Saliva Collection Device— 510(k) K223497

Name: FDA 510(k) clearance K223497
Creator: U.S. Food and Drug Administration
Published: 2023-02-17

Substantially Equivalent

Spectrum Solutions, LLC

FDA 510(k) clearance K223497 for Spectrum Saliva Collection Device, Substantially Equivalent on 2023-02-17. Applicant: Spectrum Solutions, LLC. Device class: 2.

Clearance details

Applicant: Spectrum Solutions, LLC
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2022-11-21
Decision date: 2023-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, 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.