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UTAK LABORATORIES, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
25020 AVENUE TIBBITTS, VALENCIA, CA, 91355
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
2022375
DUNS Number
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Catalogue (1969)

Page 40 of 40
DeviceModel / ReferenceRegistriesClassStatus
Anticonvulsants Toxicology Control K800882
FDA 510(k)
Class IActive
Cardiacs Ii Toxicology Control K800884
FDA 510(k)
Class IActive
Serum Clonazepam Toxicology Control K862421
FDA 510(k)
Class IActive
Tricyclic Antidepressnats Vi K831737
FDA 510(k)
Class IActive
Amoxapine 8-Hydro-Xyamoxapine K831734
FDA 510(k)
Class IActive
Caffine Toxicology Control K831738
FDA 510(k)
Class IActive
Benzodiazepines Toxicology Control K862418
FDA 510(k)
Class IActive
Tricyclic Antidepressant Ii Tx Control K800889
FDA 510(k)
Class IActive
Utak-Stabbs Toxicology Control K862420
FDA 510(k)
Class IActive
Hypnotics Plus Acetaminophen Tx Control K800886
FDA 510(k)
Class IActive
Barbiturates Toxicology Control K800885
FDA 510(k)
Class IActive
Flurazepam Toxicology Control K831741
FDA 510(k)
Class IActive
Pentobarbital Toxicology Control K831739
FDA 510(k)
Class IActive
Tricyclic Antidepressants I Tx Control K800888
FDA 510(k)
Class IActive
Serum Vancomycin Toxicology Control K862419
FDA 510(k)
Class IActive
Cardiacs I Toxicology Control K800883
FDA 510(k)
Class IActive
Maprotiline K831735
FDA 510(k)
Class IActive
Hypnotics Plus Salicylate Tx Control K800887
FDA 510(k)
Class IActive
Utak Laboratories Toxicology Control K903061
FDA 510(k)
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 20, 2020Z-2407-2020—terminated

The product has an incorrect reference value for cadmium and an incorrect expected range.