Data / Medical devices / United States / Novaflux, Inc.
Novaflux, Inc.: FDA-registered device maker in Princeton, NJ, United States, 1 510(k) clearance
Novaflux, Inc. is registered with the FDA (registration 3002735238) in Princeton, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 3, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002735238
- Address
- 1 Airport Place Suite 1, Princeton, NJ, United States, 08540
- Owner or operator
- NovaFlux, Inc. (10035626)
- Roles
- Manufacturer
- First device listed
- March 10, 2011
- Registered through
- 2026
- Brand names listed
- ClearFlux Dialyzer Reprocessing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer Reprocessing System | LIF | 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 |
|---|---|---|---|---|---|---|
| November 3, 2010 | K091360 | CLEARFLUX DIALYZER REPROCESSING SYSTEM | LIF | Substantially Equivalent | Novaflux Technologies | accessdata.fda.gov |
Compare with other makers
Updated November 3, 2010. 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.