Cleared Dual Track

Nano-Check? RSV Test

K240280 · Nano-Ditech Corporation · Microbiology

Jul 2024

Decision

180d

Days

Class 1

Risk

About This 510(k) Submission

K240280 is an FDA 510(k) clearance for the Nano-Check? RSV Test, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on July 30, 2024, 180 days after receiving the submission on February 1, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K240280 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2024
Decision Date	July 30, 2024
Days to Decision	180 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3480