Dewin Blastocyst Medium (with HSA and without HSA)— 510(k) K231370

Name: FDA 510(k) clearance K231370
Creator: U.S. Food and Drug Administration
Published: 2023-08-04

Substantially Equivalent

Donnevie Medical Technology (Shanghai) Co. , Ltd.

FDA 510(k) clearance K231370 for Dewin Blastocyst Medium (with HSA and without HSA), Substantially Equivalent on 2023-08-04. Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2023-05-12
Decision date: 2023-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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