FDA 510(k)

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

Número K: K252672 · 2026-02-20

Data da decisão2026-02-20

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) is the device name listed in this FDA 510(k) record. The listed applicant is Casebioscience, Inc.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K252672. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)?

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Casebioscience, Inc.. The 510(k) number is K252672.

When did CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) receive FDA 510(k) clearance?

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) received FDA 510(k) clearance on 2026-02-20, under 510(k) number K252672.

Who is the listed applicant for CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)?

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

What is the FDA product code for CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)?

The FDA product code for CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) is MQL.

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Outros registros que listam Casebioscience, Inc. como candidato(a)

K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

Dispositivos Relacionados (Código: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation 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 K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Fonte oficial

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