Nano-Ditech Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252283Nano-Check Influenza A+B TestJanuary 15, 2026
K243561Nano-Check Influenza+COVID-19 Dual TestJune 17, 2025
K240280Nano-Check™ RSV TestJuly 30, 2024
K231187Nano-Check™ COVID-19 Antigen TestJanuary 23, 2024
K102131NANO-CHECK AMI CTNI CARDIAC MARKER TESTOctober 20, 2010
K102441NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBINOctober 20, 2010