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FDA 510(k)

1-Step Culture Medium

K-Number: K191063 · 2019-08-23

ApplicantShenzhen Vitavitro Biotech Co., Ltd.
Decision Date2019-08-23
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

1-Step Culture Medium is a medical device manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-08-23 under approval number K191063. 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 1-Step Culture Medium?

1-Step Culture Medium is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K191063.

When was 1-Step Culture Medium approved by the FDA?

1-Step Culture Medium received FDA 510(k) clearance on 2019-08-23, under approval number K191063.

What company makes 1-Step Culture Medium?

1-Step Culture Medium is manufactured by Shenzhen Vitavitro Biotech Co., Ltd..

What is the FDA product code for 1-Step Culture Medium?

The FDA product code for 1-Step Culture Medium is MQL.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Shenzhen Vitavitro Biotech Co., Ltd.

K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

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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