Biochemical Diagnostics, Inc.

Biochemical Diagnostics, Inc. holds 2 FDA 510(k) medical device clearances, first cleared 2013, most recent 2016, with 1 FDA device recall on record.

FDA recalls by Biochemical Diagnostics, Inc.

Z-0328-2016 — CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.Class III·Terminated·2015-09-14

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Biochemical Diagnostics, Inc.

K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesCode DIF·2016-02-23
K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZCode DIF·2013-12-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for Biochemical Diagnostics, Inc.

FDA recalls by Biochemical Diagnostics, Inc.

Recent clearances by Biochemical Diagnostics, Inc.