Biochemical Diagnostics, Inc.

Medical device manufacturer in Edgewood, NY.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine…DIF · Traditional 02/23/2016SE
K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/NzDIF · Traditional 12/16/2013SE

Recalls

RecallProductInitiated
Z-0328-2016 Class IIICONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage -…CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared… 09/14/2015Terminated