Data / Medical devices / United States / Elite Sourcing And Logistics LLC
Elite Sourcing And Logistics LLC: FDA-registered device maker in Denver, CO, United States, 1 510(k) clearance
Elite Sourcing And Logistics LLC is registered with the FDA (registration 3011709181) in Denver, CO, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011709181
- Address
- 11000 E 51st Avenue, Denver, CO, United States, 80239
- Owner or operator
- Elite Sourcing and Logistics LLC (10076262)
- Roles
- Repackager or relabeler
- First device listed
- January 25, 2023
- Registered through
- 2026
- Brand names listed
- Proov Check, Proov Complete, Proov Confirm, Proov Empower
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | QKE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 10, 2013 | K123703 | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) | LCX | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Immunoassay, Pregnanediol Glucuronide, Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated April 10, 2013. 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.