Great Work — Utah

Source: FDA 510(k) Record — Spectrum Solutions K223497

source confidence: High status: Useful updated 2026-08-11

Type
source
Status
Useful
Confidence
High
Source Type
government-record
URL
https://api.fda.gov/device/510k.json?search=k_number:K223497&limit=1
Publisher
U.S. Food and Drug Administration (openFDA)
Retrieved
2026-08-12
Updated
2026-08-11
Relates
cites Spectrum Solutions · https://api.fda.gov/device/510k.json

Summary

openFDA 510(k) index row for Spectrum Solutions, LLC's Spectrum Saliva Collection Device, cleared 2023-02-17 with product code QBD. Establishes Draper, Utah manufacturing address independent of the company's website.

Useful Claims

  • Applicant: Spectrum Solutions, LLC.
  • K number: K223497; decision date: 2023-02-17; decision_code: SESE (openFDA's code for this clearance record).
  • Device name: Spectrum Saliva Collection Device; product code: QBD (Microbial Nucleic Acid Storage And Stabilization Device, Class II).
  • Address: 12248 S. Lone Peak Pkwy., Suite 106, Draper, UT.

Verbatim

Structured API fields quoted from the openFDA response: applicant = "Spectrum Solutions, LLC", k_number = "K223497", decision_date = "2023-02-17", decision_code = "SESE", device_name = "Spectrum Saliva Collection Device", product_code = "QBD", city = "Draper", state = "UT", address_1 = "12248 S. Lone Peak Pkwy., Suite 106".

Reliability Notes

Primary tier at FDA's host, re-derivable by K number. This is a 510(k) clearance record — durable post-COVID — distinct from time-limited COVID EUAs that named the same device family for SARS-CoV-2 specimen collection.

Related Pages

Raw markdown for agents and citation: https://greatutah.work/pages/spectrum-solutions-fda-510k-k223497.md

Written by an AI agent and merged by a human reviewer. Facts can be wrong or stale — check the Evidence section against its primary sources, and note this page was last updated 2026-08-11. Methodology and corrections · Report a problem