FDA.report

510(k) K240797

Device
PPH Saliva Collection Kit
Applicant
Permantis Public Health
510(k) number
K240797
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-11
Date received
2024-03-22
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
Robert Darnell
Address
P.O. Box 941 New York NY US 10021 10021

FDA Registration Numbers

Source Documents

510(k) summary PDF

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