FDA Import Refusal AEK-8022270-3/11/1 — Bionote, Inc.

Bionote, Inc. — FEI 3010847152

The FDA refused shipment AEK-8022270-3/11/1 from Bionote, Inc. (South Korea) on Nov 23, 2020. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charge: 508 This firm has 4 other import refusals on record.

Refusal details

Date
Nov 23, 2020
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
508

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