FDA Import Refusal 88H-0220063-9/11/2 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3012133212

The FDA refused shipment 88H-0220063-9/11/2 from SD Biosensor, Inc. (South Korea) on Feb 16, 2022. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Feb 16, 2022
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
508

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