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FDA 510(k)

Rapid-i™ Kit

K-Number: K181461 · 2019-01-04

ApplicantVitrolife Sweden AB
Decision Date2019-01-04
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Rapid-i™ Kit is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2019-01-04 under 510(k) 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. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K181461.

When did Rapid-i™ Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Rapid-i™ Kit?

The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.

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

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

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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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