Rapid-i Kit— 510(k) K181461

Substantially Equivalent

Vitrolife Sweden AB

FDA 510(k) clearance K181461 for Rapid-i Kit, Substantially Equivalent on 2019-01-04. Applicant: Vitrolife Sweden AB.

Clearance details

Applicant: Vitrolife Sweden AB
Product code: Code MQK
Advisory panel: Obstetrics/Gynecology
Date received: 2018-06-04
Decision date: 2019-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Västra Frölunda, SE

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