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FDA 510(k)

SepaSperm Washing Solution, SepaSperm Solution

K-Number: K190199 · 2019-09-26

ApplicantKitazato Corporation
Decision Date2019-09-26
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SepaSperm Washing Solution, SepaSperm Solution is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K190199. 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 SepaSperm Washing Solution, SepaSperm Solution?

SepaSperm Washing Solution, SepaSperm Solution is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Kitazato Corporation. The 510(k) number is K190199.

When did SepaSperm Washing Solution, SepaSperm Solution receive FDA 510(k) clearance?

SepaSperm Washing Solution, SepaSperm Solution received FDA 510(k) clearance on 2019-09-26, under 510(k) number K190199.

Who is the listed applicant for SepaSperm Washing Solution, SepaSperm Solution?

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 SepaSperm Washing Solution, SepaSperm Solution?

The FDA product code for SepaSperm Washing Solution, SepaSperm Solution 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])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAK192845Sperm Freeze, Sperm FridgeK192540Kitazato ET Catheters

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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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