Utak Laboratories Inc
Valencia, CA, US
UTAK LABORATORIES, INC. appears in FDA device records in Valencia, CA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Utak Laboratories Inc between 1980 and 1991. The busiest year on record is 1980, with 8. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 8 |
| 1981 | 1 |
| 1983 | 8 |
| 1986 | 4 |
| 1988 | 1 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL | JJY | Substantially Equivalent | |
| K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K862420 | UTAK-STABBS TOXICOLOGY CONTROL | JJY | Substantially Equivalent | |
| K831736 | TRICYCLIC ANTIDEPRESSANTS | DIF | Substantially Equivalent | |
| K831741 | FLURAZEPAM TOXICOLOGY CONTROL | DIF | Substantially Equivalent | |
| K831738 | CAFFINE TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K831735 | MAPROTILINE | LAS | Substantially Equivalent | |
| K831734 | AMOXAPINE 8-HYDRO-XYAMOXAPINE | DIF | Substantially Equivalent | |
| K831737 | TRICYCLIC ANTIDEPRESSNATS VI | DIF | Substantially Equivalent | |
| K831740 | DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE | DIF | Substantially Equivalent | |
| K831739 | PENTOBARBITAL TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K810201 | TOXICOLOGY CONTROL | LAS | Substantially Equivalent | |
| K800888 | TRICYCLIC ANTIDEPRESSANTS I TX CONTROL | DIF | Substantially Equivalent | |
| K800889 | TRICYCLIC ANTIDEPRESSANT II TX CONTROL | DIF | Substantially Equivalent | |
| K800887 | HYPNOTICS PLUS SALICYLATE TX CONTROL | DIF | Substantially Equivalent | |
| K800886 | HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL | DIF | Substantially Equivalent | |
| K800885 | BARBITURATES TOXICOLOGY CONTROL | DIF | Substantially Equivalent | |
| K800884 | CARDIACS II TOXICOLOGY CONTROL | DIF | Substantially Equivalent | |
| K800883 | CARDIACS I TOXICOLOGY CONTROL | DIF | Substantially Equivalent | |
| K800882 | ANTICONVULSANTS TOXICOLOGY CONTROL | DIF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2022375 | 2022375 | UTAK LABORATORIES, INC. | 25020 AVENUE TIBBITTS, VALENCIA, CA 91355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2407-2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics. | The product has an incorrect reference value for cadmium and an incorrect expected range. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain