FDA 510(k)

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Numéro K : K153267 · 2016-07-22

Date de décision2016-07-22

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K153267. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash?

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Origio A/S. The 510(k) number is K153267.

When did ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash receive FDA 510(k) clearance?

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash received FDA 510(k) clearance on 2016-07-22, under 510(k) number K153267.

Who is the listed applicant for ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash?

The FDA product code for ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash is MQL.

Essais cliniques associés

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Autres dossiers indiquant Origio A/S en tant que demandeur

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Dispositifs connexes (Code : 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

Source officielle

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