Quantimetrix Corporation

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2257-2018Class IIIDropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-ofDecember 21, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K152117Dropper hsCRP High Sensitivity CRP ControlApril 21, 2016