CLEARinse CTS Specimen Collection and Transport System— 510(k) K221664

Name: FDA 510(k) clearance K221664
Creator: U.S. Food and Drug Administration
Published: 2023-07-03

Substantially Equivalent

Aardvark Medical, Inc.

FDA 510(k) clearance K221664 for CLEARinse CTS Specimen Collection and Transport System, Substantially Equivalent on 2023-07-03. Applicant: Aardvark Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aardvark Medical, Inc.
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2022-06-08
Decision date: 2023-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ross, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBD

view all

K242820 — Puritan PurSafe Plus Collection and Transport System2025-05-27
K240797 — PPH Saliva Collection Kit2024-10-11
K222771 — Sample Preservative Fluid2024-06-26
K233324 — Molecular Transport Media - MTM2024-06-17
K221547 — InActiv Blue2024-06-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.