Assuramed

FDA Regulatory Profile

Assuramed appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2196-2013, Class II) was initiated on July 16, 2013.

Summary

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

Recent Recalls

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