FDA Import Refusal 799-8496706-5/11/1 — Bionote, Inc.

Bionote, Inc. — FEI 3010847152

The FDA refused shipment 799-8496706-5/11/1 from Bionote, Inc. (South Korea) on Oct 16, 2020. The refused product falls under Devices — COVID-19 TEST HOME COLLECTION KIT DEVICES. Cited charge: 508 This firm has 4 other import refusals on record.

Refusal details

Date
Oct 16, 2020
Country
South Korea
Product Category
Devices
Product Code
83QLW COVID-19 TEST HOME COLLECTION KIT DEVICES
Charges
508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.