Data / Medical devices / United States / Nowdiagnostics, Inc.
Nowdiagnostics, Inc.: FDA-registered device maker in Springdale, AR, United States, 2 510(k) clearances
Nowdiagnostics, Inc. is registered with the FDA (registration 3010864358) in Springdale, AR, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010864358
- Address
- 1200 Stewart PL, Springdale, AR, United States, 72764
- Owner or operator
- Now Diagnostics, Inc. (10048184)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- December 15, 2014
- Registered through
- 2026
- Brand names listed
- ADEXUSDx, ADEXUSDx Syphilis controls, ADEXUSDx hCG controls, First to Know Pregnancy Test, First to Know Syphilis Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer for export | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users | SBZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | 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 |
|---|---|---|---|---|---|---|
| August 16, 2024 | DEN230090 | First To Know Syphilis Test | SBZ | Unknown | Nowdiagnostics | accessdata.fda.gov |
| March 18, 2004 | K033297 | ZAP HCG TEST, MODEL 8001 | JHI | Substantially Equivalent | Zbx Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated August 16, 2024. 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.