FDA.report

510(k) K223497

Device
Spectrum Saliva Collection Device
Applicant
Spectrum Solutions, LLC
510(k) number
K223497
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-17
Date received
2022-11-21
Regulation
866.2950
Classification name
Microbial Nucleic Acid Storage And Stabilization Device
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Katie Compton
Address
12248 S. Lone Peak Pkwy., Suite 106 Draper UT US 84020 84020

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850015033001BioMAXSpectrum Solutions L.L.C.2023-06-21

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