Data / Medical devices / United States / Spectrum Solutions LLC
Spectrum Solutions LLC: FDA-registered device maker in Draper, UT, United States, 1 510(k) clearance
Spectrum Solutions LLC is registered with the FDA (registration 3012758946) in Draper, UT, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012758946
- Address
- 12278 S Lone Peak Pkwy Ste 106, Draper, UT, United States, 84020
- Owner or operator
- Spectrum Solutions LLC (10059867)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 14, 2022
- Registered through
- 2026
- Brand names listed
- Enable Blood Collection Convenience Kit, SDNA-1000 Saliva Collection Device, Spectrum Solutions Saliva Collection Device, VR101 Lubricating Intravaginal Ring
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Contract manufacturer | accessdata.fda.gov |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Manufacturer | accessdata.fda.gov |
| Personal Lubricant Ring | QPD | 2 | Contract manufacturer | accessdata.fda.gov |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | N | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2023 | K223497 | Spectrum Saliva Collection Device | QBD | Substantially Equivalent | Spectrum Solutions, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Microbial Nucleic Acid Storage And Stabilization Device
- All makers of Reagents, 2019-Novel Coronavirus Nucleic Acid
Updated February 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.