Data / Medical devices / United States / Imedrix Diagnostics Corporation
Imedrix Diagnostics Corporation: FDA-registered device maker in Chester, NJ, United States, 1 510(k) clearance
Imedrix Diagnostics Corporation is registered with the FDA (registration 3030639099) in Chester, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030639099
- Address
- 6 Windy Top Lane, Chester, NJ, United States, 07930
- Owner or operator
- Imedrix Diagnostics Corporation (10090136)
- Roles
- Specification developer
- First device listed
- February 20, 2024
- Registered through
- 2026
- Brand names listed
- Kardioscreen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Specification developer | 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 10, 2020 | K191692 | KardioScreen | DPS | Substantially Equivalent | Imedrix Inc. (Formerly Piitech Inc.) | accessdata.fda.gov |
Compare with other makers
Updated January 10, 2020. 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.