FDA 510(k)

Dewin Blastocyst Medium (with HSA and without HSA)

Numéro K : K231370 · 2023-08-04

DemandeurDonnevie Medical Technology (Shanghai) Co. , Ltd.

Date de décision2023-08-04

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Dewin Blastocyst Medium (with HSA and without HSA) is the device name listed in this FDA 510(k) record. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K231370. 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 Dewin Blastocyst Medium (with HSA and without HSA)?

Dewin Blastocyst Medium (with HSA and without HSA) is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K231370.

When did Dewin Blastocyst Medium (with HSA and without HSA) receive FDA 510(k) clearance?

Dewin Blastocyst Medium (with HSA and without HSA) received FDA 510(k) clearance on 2023-08-04, under 510(k) number K231370.

Who is the listed applicant for Dewin Blastocyst Medium (with HSA and without HSA)?

The FDA 510(k) record lists Donnevie Medical Technology (Shanghai) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dewin Blastocyst Medium (with HSA and without HSA)?

The FDA product code for Dewin Blastocyst Medium (with HSA and without HSA) is MQL.

Essais cliniques associés

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Autres dossiers indiquant Donnevie Medical Technology (Shanghai) Co. , Ltd. en tant que demandeur

K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

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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