FDA Import Refusal 799-8034951-9/22/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3008959428

The FDA refused shipment 799-8034951-9/22/1 from SD Biosensor, Inc. (South Korea) on Jun 20, 2025. The refused product falls under Devices — SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER. Cited charges: 118,3280,341,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Jun 20, 2025
Country
South Korea
Product Category
Devices
Product Code
75NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Charges
118,3280,341,508

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