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510(k) K221664

CLEARinse CTS Specimen Collection and Transport System by Aardvark Medical, Inc. — Product Code QBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2023
Date Received
June 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microbial Nucleic Acid Storage And Stabilization Device
Device Class
Class II
Regulation Number
866.2950
Review Panel
MI
Submission Type

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

Other clearances by Aardvark Medical, Inc.

  • K082762 — AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE (November 12, 2008)

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