Biochemical Diagnostics Inc

FDA Regulatory Profile

Biochemical Diagnostics Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0328-2016, Class III) was initiated on September 14, 2015. Its most recent 510(k) clearance was granted on February 23, 2016.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0328-2016Class IIICONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT DSeptember 14, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid CFebruary 23, 2016
K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZDecember 16, 2013