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FDA 510(k)

Cryotop Vitrification Kit and Cryotop Thawing Kit

K-Number: K160864 · 2016-10-07

ApplicantKitazato Biopharma Co., Ltd.
Decision Date2016-10-07
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cryotop Vitrification Kit and Cryotop Thawing Kit is a medical device manufactured by Kitazato Biopharma Co., Ltd.. It received FDA 510(k) clearance on 2016-10-07 under approval number K160864. 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 Cryotop Vitrification Kit and Cryotop Thawing Kit?

Cryotop Vitrification Kit and Cryotop Thawing Kit is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Kitazato Biopharma Co., Ltd.. The 510(k) number is K160864.

When was Cryotop Vitrification Kit and Cryotop Thawing Kit approved by the FDA?

Cryotop Vitrification Kit and Cryotop Thawing Kit received FDA 510(k) clearance on 2016-10-07, under approval number K160864.

What company makes Cryotop Vitrification Kit and Cryotop Thawing Kit?

Cryotop Vitrification Kit and Cryotop Thawing Kit is manufactured by Kitazato Biopharma Co., Ltd..

What is the FDA product code for Cryotop Vitrification Kit and Cryotop Thawing Kit?

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

Other Devices by Kitazato Biopharma Co., Ltd.

K160863PBS(-), Phosphate Buffered Saline K160142MINERAL OIL K153027Cryotop US

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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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