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FDA 510(k)

Sperm Freeze, Sperm Fridge

K-Number: K192845 · 2020-08-17

ApplicantKitazato Corporation
Decision Date2020-08-17
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sperm Freeze, Sperm Fridge is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2020-08-17 under approval number K192845. 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 Sperm Freeze, Sperm Fridge?

Sperm Freeze, Sperm Fridge is a medical device that received FDA 510(k) clearance on 2020-08-17. It is manufactured by Kitazato Corporation. The 510(k) number is K192845.

When was Sperm Freeze, Sperm Fridge approved by the FDA?

Sperm Freeze, Sperm Fridge received FDA 510(k) clearance on 2020-08-17, under approval number K192845.

What company makes Sperm Freeze, Sperm Fridge?

Sperm Freeze, Sperm Fridge is manufactured by Kitazato Corporation.

What is the FDA product code for Sperm Freeze, Sperm Fridge?

The FDA product code for Sperm Freeze, Sperm Fridge is MQL.

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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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