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510(k) K181461

Rapid-i™ Kit by Vitrolife Sweden AB — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2019
Date Received
June 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

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