FDA 510(k)

Rapid-i Kit

K-Number: K181461 · 2019-01-04

Decision Date2019-01-04

Product CodeMQK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Rapid-i Kit is a medical device manufactured by Vitrolife Sweden AB. It received FDA 510(k) clearance on 2019-01-04 under approval number K181461. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid-i Kit?

Rapid-i Kit is a medical device that received FDA 510(k) clearance on 2019-01-04. It is manufactured by Vitrolife Sweden AB. The 510(k) number is K181461.

When was Rapid-i Kit approved by the FDA?

Rapid-i Kit received FDA 510(k) clearance on 2019-01-04, under approval number K181461.

What company makes Rapid-i Kit?

Rapid-i Kit is manufactured by Vitrolife Sweden AB.

What is the FDA product code for Rapid-i Kit?

The FDA product code for Rapid-i Kit is MQK.

Other Devices by Vitrolife Sweden AB

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Related Devices (Code: MQK)

K162051CryotecReprolife, Inc. K153027Cryotop USKitazato Biopharma Co., Ltd. K162640iVitri EZReprobitech Corp. K162833VitriGuardOrigio A/S K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation K180740VitriGuardOrigio A/S

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.