FDA Import Refusal 799-7288364-8/11/1 — CALTH INC.

CALTH INC. — FEI 3017000332

The FDA refused shipment 799-7288364-8/11/1 from CALTH INC. (South Korea) on Mar 22, 2022. 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
Mar 22, 2022
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
508

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