Data / Medical devices / United States / NOVODX Corporation
NOVODX Corporation: FDA-registered device maker in Jupiter, FL, United States, 1 510(k) clearance
NOVODX Corporation is registered with the FDA (registration 3030230672) in Jupiter, FL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030230672
- Address
- 110 Front St Ste 300, Jupiter, FL, United States, 33477
- Owner or operator
- NOVODX Corporation (10089550)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 29, 2023
- Registered through
- 2026
- Brand names listed
- GoldN Easy to Use FSH Test, GoldN Easy to Use Pregnancy Test, GoldN Easy to Use Vaginal pH Test, GoldN Easy to Use Ovulation Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 5, 2024 | K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent | Assure Tech. (Hangzhou) Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dye-Indicator, Ph (Urinary, Non-Quantitative)
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
Updated February 5, 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.