Nanoentek USA, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K162378FREND PSA PLUS (reagent cartridge)May 17, 2017
K162754FREND Vitamin D Test SystemJanuary 12, 2017
K153577FREND Testosterone Test SystemOctober 14, 2016
K152422FREND™ Free T4 Test SystemFebruary 17, 2016
K131928FREND TSH (REAGENT CARTRIDGE)March 14, 2014