Cleared Traditional

Molecular Transport Media - MTM

K233324 · Alb Luz · Microbiology

Jun 2024

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K233324 is an FDA 510(k) clearance for the Molecular Transport Media - MTM, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Alb Luz (Valinhos, BR). The FDA issued a Cleared decision on June 17, 2024, 262 days after receiving the submission on September 29, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K233324 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2023
Decision Date	June 17, 2024
Days to Decision	262 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.