Utak Laboratories, Inc.

Medical device manufacturer in Valencia, CA.

23510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K903061Utak Laboratories Toxicology ControlLAS · Traditional 04/12/1991SE
K883147Trace Elements Serum Toxicology ControlJJY · Traditional 10/06/1988SE
K862419Serum Vancomycin Toxicology ControlLAS · Traditional 11/13/1986SE
K862418Benzodiazepines Toxicology ControlLAS · Traditional 11/13/1986SE
K862421Serum Clonazepam Toxicology ControlLAS · Traditional 11/05/1986SE
K862420Utak-Stabbs Toxicology ControlJJY · Traditional 08/04/1986SE
K831736Tricyclic AntidepressantsDIF · Traditional 07/28/1983SE
K831741Flurazepam Toxicology ControlDIF · Traditional 07/26/1983SE
K831738Caffine Toxicology ControlLAS · Traditional 07/26/1983SE
K831735MaprotilineLAS · Traditional 07/26/1983SE
K831734Amoxapine 8-HYDRO-XYAMOXAPINEDIF · Traditional 07/26/1983SE
K831737Tricyclic Antidepressnats ViDIF · Traditional 07/19/1983SE
K831740Disopyramide N-DesalkyldisopyramideDIF · Traditional 07/06/1983SE
K831739Pentobarbital Toxicology ControlLAS · Traditional 07/06/1983SE
K810201Toxicology ControlLAS · Traditional 02/04/1981SE
K800888Tricyclic Antidepressants I TX ControlDIF · Traditional 05/02/1980SE
K800889Tricyclic Antidepressant II TX ControlDIF · Traditional 04/29/1980SE
K800887Hypnotics Plus Salicylate TX ControlDIF · Traditional 04/29/1980SE
K800886Hypnotics Plus Acetaminophen TX ControlDIF · Traditional 04/29/1980SE
K800885Barbiturates Toxicology ControlDIF · Traditional 04/29/1980SE
K800884Cardiacs II Toxicology ControlDIF · Traditional 04/29/1980SE
K800883Cardiacs I Toxicology ControlDIF · Traditional 04/29/1980SE
K800882Anticonvulsants Toxicology ControlDIF · Traditional 04/29/1980SE

Recalls

RecallProductInitiated
Z-2407-2020 Class IIIUtak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label…The product has an incorrect reference value for cadmium and an incorrect expected range. 03/20/2020Terminated