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510(k) K240797

PPH Saliva Collection Kit by Permantis Public Health — Product Code QBD

K240797 is an FDA 510(k) premarket notification submitted by Permantis Public Health for the device "PPH Saliva Collection Kit". The FDA issued a decision of Substantially Equivalent on October 11, 2024. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2024
Date Received
March 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microbial Nucleic Acid Storage And Stabilization Device
Device Class
Class II
Regulation Number
866.2950
Review Panel
MI
Submission Type

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

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  • K221547 — InActiv Blue (June 11, 2024)
  • K212878 — Sample preservation solution (April 8, 2024)
  • K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit (September 28, 2023)
  • K221664 — CLEARinse CTS Specimen Collection and Transport System (July 3, 2023)
  • K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (April 3, 2023)
  • K223497 — Spectrum Saliva Collection Device (February 17, 2023)
  • K220059 — Biosci™ Inactivated Transport Medium, Biosci™ ITM (January 19, 2023)

FDA data resources