Cleared Traditional

BlueStar and BlueStar Rx

K230813 · Welldoc, Inc. · Chemistry
Jul 2023
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K230813 is an FDA 510(k) clearance for the BlueStar and 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 July 28, 2023, 126 days after receiving the submission on March 24, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K230813 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2023
Decision Date July 28, 2023
Days to Decision 126 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