Cleared Traditional

Sample Preservative Fluid

K222771 · Hangzhou Bioer Technology Co., Ltd. · Microbiology

Jun 2024

Decision

651d

Days

Class 2

Risk

About This 510(k) Submission

K222771 is an FDA 510(k) clearance for the Sample Preservative Fluid, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Hangzhou Bioer Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 26, 2024, 651 days after receiving the submission on September 14, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K222771 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2022
Decision Date	June 26, 2024
Days to Decision	651 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.