Acon Biotech (Hangzhou) Co., Ltd.

FDA Regulatory Profile

Acon Biotech (Hangzhou) Co., Ltd. appears in FDA public data with 1 recall, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0945-2022, Class II) was initiated on January 9, 2022.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0945-2022Class IIFlowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE markedJanuary 9, 2022