Cleared Traditional

VitaVitro? Fertilization Medium, VitaVitro? Gamete Buffer Medium, VitaVitro? Flushing Buffer Medium

K200408 · Shenzhen Vitavitro Biotech Co., Ltd. · Obstetrics & Gynecology
Oct 2020
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K200408 is an FDA 510(k) clearance for the VitaVitro? Fertilization Medium, VitaVitro? Gamete Buffer Medium, VitaVitro? Flushing Buffer Medium, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2020, 240 days after receiving the submission on February 19, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K200408 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2020
Decision Date October 16, 2020
Days to Decision 240 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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