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FDA 510(k)

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

K-Number: K193522 · 2020-08-25

ApplicantKitazato Corporation
Decision Date2020-08-25
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Kitazato Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmK251305Ultra-Fast Vitri; Ultra-Fast WarmK200249Sequential 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 FridgeK192540Kitazato ET CathetersK190199SepaSperm Washing Solution, SepaSperm Solution

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Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin 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 CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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