FDA 510(k)

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

Numéro K : K193522 · 2020-08-25

Date de décision2020-08-25

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K193522. 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 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Kitazato Corporation. The 510(k) number is K193522.

When did iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA receive FDA 510(k) clearance?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA received FDA 510(k) clearance on 2020-08-25, under 510(k) number K193522.

Who is the listed applicant for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

The FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is MQL.

Essais cliniques associés

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Autres dossiers indiquant Kitazato Corporation en tant que demandeur

K260248Ultra-Fast Warm K251305Ultra-Fast Vitri; Ultra-Fast Warm K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters K190199SepaSperm Washing Solution, SepaSperm Solution

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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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