Amalgam Rx, Inc

FDA Device Registration & Listing · Wilmington, DE, US · Registration 3013498633

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013498633
FEI Number
3013498633
Entity Name
Amalgam Rx, Inc
City/State/Country
Wilmington, DE, US
Establishment Address
1007 N Orange St Ste 400, Wilmington, DE 19801, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Amalgam Rx, Inc (Owner Number: 10054581)
Owner / Operator Contact Address
206 Alapocas Drive, Wilmington, DE 19803, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161865
PMA Number
N/A

All Registered Proprietary Names

iSage Rx Dose Check iSage Rx™ (iSage Rx Basal Insulin Titration) Dose Check

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDC Calculator, Drug Dose Anesthesiology Class 2 868.1890 2024-09-30
NDC Calculator, Drug Dose Anesthesiology Class 2 868.1890 2017-04-05

Official Correspondent

Ryan Sysko

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Amalgam Rx, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013498633. Last updated year: 2026. Please use registration number 3013498633 when referencing this establishment in official correspondence.
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