Assuramed

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2198-2013Class IIProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettJuly 16, 2013
Z-2196-2013Class IIDiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with July 16, 2013
Z-2197-2013Class IIHemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares)July 16, 2013