Data / Medical devices / United States / DxNow Inc.
DxNow Inc.: FDA-registered device maker in Gaithersburg, MD, United States, 1 510(k) clearance
DxNow Inc. is registered with the FDA (registration 3014527900) in Gaithersburg, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014527900
- Address
- 401 Professional Drive Suite 130, Gaithersburg, MD, United States, 20879
- Owner or operator
- DxNow, Inc. (10057557)
- Roles
- Repackager or relabeler
- First device listed
- April 24, 2018
- Registered through
- 2026
- Brand names listed
- ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | 2 | 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 |
|---|---|---|---|---|---|---|
| March 8, 2018 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | MQK | Substantially Equivalent | Dxnow, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 8, 2018. 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.