Cleared Traditional

Viral Transport Media (VTM)

K232454 · Alb Luz · Microbiology

May 2024

Decision

263d

Days

Class 1

Risk

About This 510(k) Submission

K232454 is an FDA 510(k) clearance for the Viral Transport Media (VTM), a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Alb Luz (Valinhos, BR). The FDA issued a Cleared decision on May 3, 2024, 263 days after receiving the submission on August 14, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K232454 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2023
Decision Date	May 03, 2024
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF