FDA Import Refusal 799-2286118-1/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3008959428

The FDA refused shipment 799-2286118-1/11/1 from SD Biosensor, Inc. (South Korea) on May 17, 2021. The refused product falls under Devices — REAGENT, CORONAVIRUS SEROLOGICAL. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal details

Date
May 17, 2021
Country
South Korea
Product Category
Devices
Product Code
83QKO REAGENT, CORONAVIRUS SEROLOGICAL
Charges
508

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