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FDA Import Refusal 799-8272716-4/11/1 — CALTH INC.

CALTH INC. — FEI 3017000332

The FDA refused shipment 799-8272716-4/11/1 from CALTH INC. (South Korea) on Aug 21, 2020. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charge: 508 This firm has 3 other import refusals on record.

Refusal details

Date
Aug 21, 2020
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
508

Other import refusals

FDA data resources

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