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FDA 510(k)

Vitrification Solution Set and Warming Solution Set

K-Number: K233846 · 2024-08-27

ApplicantEcmpc, LLC
Decision Date2024-08-27
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vitrification Solution Set and Warming Solution Set is the device name listed in this FDA 510(k) record. The listed applicant is Ecmpc, LLC. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K233846. 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 Vitrification Solution Set and Warming Solution Set?

Vitrification Solution Set and Warming Solution Set is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Ecmpc, LLC. The 510(k) number is K233846.

When did Vitrification Solution Set and Warming Solution Set receive FDA 510(k) clearance?

Vitrification Solution Set and Warming Solution Set received FDA 510(k) clearance on 2024-08-27, under 510(k) number K233846.

Who is the listed applicant for Vitrification Solution Set and Warming Solution Set?

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

What is the FDA product code for Vitrification Solution Set and Warming Solution Set?

The FDA product code for Vitrification Solution Set and Warming Solution Set is MQL.

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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