FDA.report

510(k) K221664

Device
CLEARinse CTS Specimen Collection and Transport System
Applicant
Aardvark Medical, Inc.
510(k) number
K221664
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-03
Date received
2022-06-08
Regulation
866.2950
Classification name
Microbial Nucleic Acid Storage And Stabilization Device
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Steven Bacich
Address
55 Bolinas Ave. Ross CA US 94957 94957

FDA Registration Numbers

Source Documents

510(k) summary PDF

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