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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K221547
Device Name InActiv Blue
Applicant
Fertipro NV
Industriepark Noord 32
Beernem,  BE 8730
Applicant Contact Liesbeth Faes
Correspondent
Ducks IN A Row Compliance, LLC
Bentley Dr.
Warrington,  PA  18976
Correspondent Contact Gregor P Kleinert
Classification Product Code
QBD  
Date Received05/27/2022
Decision Date 06/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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