FDA 510(k)

Vit Kit- Freeze NX and Vit Kit- Warm NX

Numéro K : K190152 · 2019-06-21

DemandeurFujifilm Irvine Scientific, Inc.

Date de décision2019-06-21

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Vit Kit- Freeze NX and Vit Kit- Warm NX is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K190152. 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 Vit Kit- Freeze NX and Vit Kit- Warm NX?

Vit Kit- Freeze NX and Vit Kit- Warm NX is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Fujifilm Irvine Scientific, Inc.. The 510(k) number is K190152.

When did Vit Kit- Freeze NX and Vit Kit- Warm NX receive FDA 510(k) clearance?

Vit Kit- Freeze NX and Vit Kit- Warm NX received FDA 510(k) clearance on 2019-06-21, under 510(k) number K190152.

Who is the listed applicant for Vit Kit- Freeze NX and Vit Kit- Warm NX?

The FDA 510(k) record lists Fujifilm Irvine Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vit Kit- Freeze NX and Vit Kit- Warm NX?

The FDA product code for Vit Kit- Freeze NX and Vit Kit- Warm NX is MQL.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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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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