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FDA 510(k)

CLEARinse CTS Specimen Collection and Transport System

K-Number: K221664 · 2023-07-03

ApplicantAardvark Medical, Inc.
Decision Date2023-07-03
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLEARinse CTS Specimen Collection and Transport System is a medical device manufactured by Aardvark Medical, Inc.. It received FDA 510(k) clearance on 2023-07-03 under approval number K221664. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARinse CTS Specimen Collection and Transport System?

CLEARinse CTS Specimen Collection and Transport System is a medical device that received FDA 510(k) clearance on 2023-07-03. It is manufactured by Aardvark Medical, Inc.. The 510(k) number is K221664.

When was CLEARinse CTS Specimen Collection and Transport System approved by the FDA?

CLEARinse CTS Specimen Collection and Transport System received FDA 510(k) clearance on 2023-07-03, under approval number K221664.

What company makes CLEARinse CTS Specimen Collection and Transport System?

CLEARinse CTS Specimen Collection and Transport System is manufactured by Aardvark Medical, Inc..

What is the FDA product code for CLEARinse CTS Specimen Collection and Transport System?

The FDA product code for CLEARinse CTS Specimen Collection and Transport System is QBD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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