Cleared Traditional

PPH Saliva Collection Kit

K240797 · Permantis Public Health · Microbiology

Oct 2024

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K240797 is an FDA 510(k) clearance for the PPH Saliva Collection Kit, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Permantis Public Health (New York, US). The FDA issued a Cleared decision on October 11, 2024, 203 days after receiving the submission on March 22, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K240797 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2024
Decision Date	October 11, 2024
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QBD — Microbial Nucleic Acid Storage And Stabilization Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.2950
Definition	Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.