FDA Import Refusal 799-0552491-3/11/1 — SD Biosensor, Inc.
The FDA refused shipment 799-0552491-3/11/1 from SD Biosensor, Inc. (South Korea) on Jan 7, 2021. The refused product falls under Devices — MULTIPLEX NUCLEIC ACID ASSAY SYSTEM, VIRAL NUCLEIC ACID IN RESPIRATORY SPECIMENS, MULTIPLE RESPIRATO. Cited charge: 508 This firm has 5 or more other import refusals on record.
Refusal details
- Date
- Jan 7, 2021
- Country
- South Korea
- Product Category
- Devices
- Product Code
- 83OCC MULTIPLEX NUCLEIC ACID ASSAY SYSTEM, VIRAL NUCLEIC ACID IN RESPIRATORY SPECIMENS, MULTIPLE RESPIRATO
- Charges
- 508