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FDA Import Refusal 336-5746142-8/10002/1 — ABBOTT DIAGNOSTICS KOREA INC

ABBOTT DIAGNOSTICS KOREA INC — FEI 3015883679

The FDA refused shipment 336-5746142-8/10002/1 from ABBOTT DIAGNOSTICS KOREA INC (South Korea) on December 2, 2025. The refused product falls under Devices — PLASMODIUM SPP. DETECTION REAGENTS. Cited charges: 118,3280,341,3905 This firm has 3 other import refusals on record.

Refusal Details

Date
December 2, 2025
Country
South Korea
Product Category
Devices
Product Code
83OAX PLASMODIUM SPP. DETECTION REAGENTS
Charges
118,3280,341,3905

Other import refusals

  • 799-7033469-3/11/1 (Mon Feb 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7140152-5/11/1 (Mon Jan 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-9352205-7/11/1 (Wed Jul 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources