FDA 510(k)

Vitrification Kit and Thawing Kit

N.º K: K171748 · 2017-12-14

Fecha de decisión2017-12-14

Código de productoMQL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vitrification Kit and Thawing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K171748. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vitrification Kit and Thawing Kit?

Vitrification Kit and Thawing Kit is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Kitazato Corporation. The 510(k) number is K171748.

When did Vitrification Kit and Thawing Kit receive FDA 510(k) clearance?

Vitrification Kit and Thawing Kit received FDA 510(k) clearance on 2017-12-14, under 510(k) number K171748.

Who is the listed applicant for Vitrification Kit and Thawing Kit?

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 Vitrification Kit and Thawing Kit?

The FDA product code for Vitrification Kit and Thawing Kit is MQL.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Kitazato Corporation como solicitante

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])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters

Ver todos los 13 dispositivos →

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 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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.