SPECTRUM SOLUTIONS LLC

FDA Device Registration & Listing · Draper, UT, US · Registration 3012758946

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012758946
FEI Number
3012758946
Entity Name
SPECTRUM SOLUTIONS LLC
City/State/Country
Draper, UT, US
Establishment Address
12278 S Lone Peak Pkwy Ste 106, Draper, UT 84020, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Spectrum Solutions LLC (Owner Number: 10059867)
Owner / Operator Contact Address
12248 S. Lone Peak Parkway #106, Draper, UT 84020, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223497
PMA Number
N/A

All Registered Proprietary Names

SDNA-1000 Saliva Collection Device VR101 Lubricating Intravaginal Ring Enable Blood Collection Convenience Kit Spectrum Solutions Saliva Collection Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2022-01-14
QPD Personal Lubricant Ring Obstetrics/Gynecology Class 2 884.5300 2023-01-24
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2024-12-16
QBD Microbial Nucleic Acid Storage And Stabilization Device Microbiology Class 2 866.2950 2023-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spectrum Solutions LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012758946. Last updated year: 2026. Please use registration number 3012758946 when referencing this establishment in official correspondence.
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