FDA Registration
Active
🇺🇸 United States
SPECTRUM SOLUTIONS LLC
Reg #: 3012758946
·
FEI: 3012758946
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SPECTRUM SOLUTIONS LLC
- Registration Number
- 3012758946
- FEI Number
- 3012758946
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12278 S Lone Peak Pkwy Ste 106
- City
- Draper
- State
- UT
- ZIP
- 84020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223497
Owner / Operator
- Firm Name
- Spectrum Solutions LLC
- Operator Number
- 10059867
- Address
- 12248 S. Lone Peak Parkway #106
- City
- Draper
- State
- UT
- Postal Code
- 84020
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2022-01-14 |
| Personal Lubricant Ring | QPD | Class 2 | Obstetrics/Gynecology | No | 2023-01-24 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2024-12-16 |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2023-06-13 |
Proprietary Names
SDNA-1000 Saliva Collection Device
VR101 Lubricating Intravaginal Ring
Enable Blood Collection Convenience Kit
Spectrum Solutions Saliva Collection Device
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)