Horiba Instruments Incorporated

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
12
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2166-2024Class IIHORIBA custom configured fluorescence instrument, modular Fluorolog-QMMarch 28, 2024
Z-0119-2020Class IIClinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # October 30, 2018