FDA 510(k)

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

Numéro K : K212410 · 2022-02-01

DemandeurShenzhen Vitavitro Biotech Co., Ltd.

Date de décision2022-02-01

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K212410. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K212410.

When did VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium receive FDA 510(k) clearance?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium received FDA 510(k) clearance on 2022-02-01, under 510(k) number K212410.

Who is the listed applicant for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

The FDA 510(k) record lists Shenzhen Vitavitro Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

The FDA product code for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is MQL.

Essais cliniques associés

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Autres dossiers indiquant Shenzhen Vitavitro Biotech Co., Ltd. en tant que demandeur

K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium K1910631-Step Culture Medium

Dispositifs connexes (Code : MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Source officielle

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