Data / Medical devices / United States / Neelyx Labs
Neelyx Labs: FDA-registered device maker in Wood Dale, IL, United States, 1 510(k) clearance
Neelyx Labs is registered with the FDA (registration 3021179642) in Wood Dale, IL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2002. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021179642
- Address
- 330 Georgetown Sq, Wood Dale, IL, United States, 60191
- Owner or operator
- Neelyx Labs, Inc (10084878)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 4, 2024
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Manufacturer | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | 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 |
|---|---|---|---|---|---|---|
| January 22, 2002 | K013465 | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | LCP | Substantially Equivalent | Diabetes Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Assay, Glycosylated Hemoglobin
Updated January 22, 2002. 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.