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FDA 510(k)

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

K-Number: K232493 · 2024-05-07

ApplicantWuhan Huchuang Union Technology Co., Ltd.
Decision Date2024-05-07
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is a medical device manufactured by Wuhan Huchuang Union Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-07 under approval number K232493. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is a medical device that received FDA 510(k) clearance on 2024-05-07. It is manufactured by Wuhan Huchuang Union Technology Co., Ltd.. The 510(k) number is K232493.

When was Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) approved by the FDA?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) received FDA 510(k) clearance on 2024-05-07, under approval number K232493.

What company makes Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is manufactured by Wuhan Huchuang Union Technology Co., Ltd..

What is the FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

The FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is MQG.

Related Clinical Trials

NCT07270250 Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING

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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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