Cleared Traditional

BlueStar Rx

K203434 · Welldoc, Inc. · Chemistry
Sep 2021
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K203434 is an FDA 510(k) clearance for the BlueStar Rx, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on September 8, 2021, 289 days after receiving the submission on November 23, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K203434 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2020
Decision Date September 08, 2021
Days to Decision 289 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