Cleared Traditional

iSage Rx

K242066 · Amalgam Rx, Inc. · Chemistry
Aug 2024
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K242066 is an FDA 510(k) clearance for the iSage Rx, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Amalgam Rx, Inc. (Wilmington, US). The FDA issued a Cleared decision on August 21, 2024, 37 days after receiving the submission on July 15, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K242066 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2024
Decision Date August 21, 2024
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890