FDA Import Refusal D79-0027124-9/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3012133212

The FDA refused shipment D79-0027124-9/11/1 from SD Biosensor, Inc. (South Korea) on Aug 12, 2021. The refused product falls under Devices — ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE. Cited charges: 118,341 This firm has 5 or more other import refusals on record.

Refusal details

Date
Aug 12, 2021
Country
South Korea
Product Category
Devices
Product Code
75JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
Charges
118,341

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