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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 the device name listed in this FDA 510(k) record. The listed applicant is Aardvark Medical, Inc.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) 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. The listed applicant is Aardvark Medical, Inc.. The 510(k) number is K221664.

When did CLEARinse CTS Specimen Collection and Transport System receive FDA 510(k) clearance?

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

Who is the listed applicant for CLEARinse CTS Specimen Collection and Transport System?

The FDA 510(k) record lists Aardvark Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: QBD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLCK240797PPH Saliva Collection KitPermantis Public HealthK222771Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.K233324Molecular Transport Media - MTMAlb LuzK221547InActiv BlueFertipro NVK212878Sample preservation solutionZhejiang Gene Science Co., Ltd.

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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