FDA 510(k)

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3

K-Number: K092963 · 2011-01-14

Decision Date2011-01-14

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 is the device name listed in this FDA 510(k) record. The listed applicant is Genx Intl., Inc.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K092963. 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 GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3?

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Genx Intl., Inc.. The 510(k) number is K092963.

When did GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 receive FDA 510(k) clearance?

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 received FDA 510(k) clearance on 2011-01-14, under 510(k) number K092963.

Who is the listed applicant for GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3?

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

What is the FDA product code for GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3?

The FDA product code for GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 is MQL.

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Other records listing Genx Intl., Inc. as applicant

K112083LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES K092667GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT K092578LIFEGLOBAL PROTEIN SUPPLEMENT K083509LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA K080395SUNIVF DISHES K070689LG SPERM FREEZING

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Related Devices (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

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.