Cleared Traditional

Dewin Blastocyst Medium (with HSA and without HSA)

K231370 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Obstetrics & Gynecology
Aug 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K231370 is an FDA 510(k) clearance for the Dewin Blastocyst Medium (with HSA and without HSA), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 4, 2023, 84 days after receiving the submission on May 12, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K231370 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2023
Decision Date August 04, 2023
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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