Cleared Traditional

Sample preservation solution

K212878 · Zhejiang Gene Science Co., Ltd. · Microbiology

Apr 2024

Decision

942d

Days

Class 2

Risk

About This 510(k) Submission

K212878 is an FDA 510(k) clearance for the Sample preservation solution, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Zhejiang Gene Science Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on April 8, 2024, 942 days after receiving the submission on September 9, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K212878 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2021
Decision Date	April 08, 2024
Days to Decision	942 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.