Cryotop Vitrification Kit and Cryotop Thawing Kit— 510(k) K160864

Name: FDA 510(k) clearance K160864
Creator: U.S. Food and Drug Administration
Published: 2016-10-07

Substantially Equivalent

Kitazato Biopharma Co., Ltd.

FDA 510(k) clearance K160864 for Cryotop Vitrification Kit and Cryotop Thawing Kit, Substantially Equivalent on 2016-10-07. Applicant: Kitazato Biopharma Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kitazato Biopharma Co., Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2016-03-29
Decision date: 2016-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fuji, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.