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FDA 510(k)

Spectrum Saliva Collection Device

K-Number: K223497 · 2023-02-17

ApplicantSpectrum Solutions, LLC
Decision Date2023-02-17
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Spectrum Saliva Collection Device is a medical device manufactured by Spectrum Solutions, LLC. It received FDA 510(k) clearance on 2023-02-17 under approval number K223497. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectrum Saliva Collection Device?

Spectrum Saliva Collection Device is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Spectrum Solutions, LLC. The 510(k) number is K223497.

When was Spectrum Saliva Collection Device approved by the FDA?

Spectrum Saliva Collection Device received FDA 510(k) clearance on 2023-02-17, under approval number K223497.

What company makes Spectrum Saliva Collection Device?

Spectrum Saliva Collection Device is manufactured by Spectrum Solutions, LLC.

What is the FDA product code for Spectrum Saliva Collection Device?

The FDA product code for Spectrum Saliva Collection Device is QBD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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