Data / Medical devices / United States / Amalgam Rx, Inc
Amalgam Rx, Inc: FDA-registered device maker in Wilmington, DE, United States, 2 510(k) clearances
Amalgam Rx, Inc is registered with the FDA (registration 3013498633) in Wilmington, DE, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013498633
- Address
- 1007 N Orange St Ste 400, Wilmington, DE, United States, 19801
- Owner or operator
- Amalgam Rx, Inc (10054581)
- Roles
- Manufacturer
- First device listed
- April 5, 2017
- Registered through
- 2026
- Brand names listed
- Dose Check, iSage Rx, iSage Rx (iSage Rx Basal Insulin Titration)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 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 21, 2024 | K242066 | iSage Rx | NDC | Substantially Equivalent | Amalgam Rx, Inc. | accessdata.fda.gov |
| March 7, 2017 | K161865 | iSage Rx (iSage Rx Basal Insulin Titration) | NDC | Substantially Equivalent | Isag Rx, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 21, 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.