Pointe Scientific, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

pointe scientific, pointe scientific, inc

Recent Recalls

NumberClassProductDate
Z-2487-2015Class IIPointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 anMay 19, 2015
Z-2764-2015Class IIIPointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle March 13, 2015
Z-2773-2015Class IIIPointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit December 12, 2014