FDA Import Refusal 799-9074079-5/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3008959428

The FDA refused shipment 799-9074079-5/11/1 from SD Biosensor, Inc. (South Korea) on Oct 21, 2020. The refused product falls under Devices — COVID-19 TEST HOME COLLECTION KIT DEVICES. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Oct 21, 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.