Nano-Check RSV Test— 510(k) K240280

Substantially Equivalent

Nano-Ditech Corporation

FDA 510(k) clearance K240280 for Nano-Check RSV Test, Substantially Equivalent on 2024-07-30. Applicant: Nano-Ditech Corporation. Device class: 1.

Clearance details

Applicant: Nano-Ditech Corporation
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2024-02-01
Decision date: 2024-07-30
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQG

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More clearances from Nano-Ditech Corporation

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K231187 — Nano-Check COVID-19 Antigen Test2024-01-23
K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST2010-10-20
K102441 — NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN2010-10-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.