Data / Medical devices / United States / Utak Laboratories, Inc.
Utak Laboratories, Inc.: FDA-registered device maker in Valencia, CA, United States, 24 510(k) clearances
Utak Laboratories, Inc. is registered with the FDA (registration 2022375) in Valencia, CA, United States. It lists 3 device types. The FDA files 24 510(k) clearances under its listings, the newest dated November 2, 1994. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2022375
- Address
- 25020 Avenue Tibbitts, Valencia, CA, United States, 91355
- Owner or operator
- UTAK LABORATORIES, I (2022375)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Amoxapine Control, Anticonvulsants Control, Barbiturates Control, Benzodiazepines Control, Caffeine Control, Cardiacs I Control, Cardiacs II Control, Clonazepam Control and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drug Mixture Control Materials | DIF | 1 | Manufacturer | accessdata.fda.gov |
| Drug Specific Control Materials | LAS | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 2, 1994 | K943422 | TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL | DIF | Substantially Equivalent | Utak Lab, Inc. | accessdata.fda.gov |
| April 12, 1991 | K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| October 6, 1988 | K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL | JJY | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| November 13, 1986 | K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| November 13, 1986 | K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| November 5, 1986 | K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| August 4, 1986 | K862420 | UTAK-STABBS TOXICOLOGY CONTROL | JJY | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 28, 1983 | K831736 | TRICYCLIC ANTIDEPRESSANTS | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 26, 1983 | K831741 | FLURAZEPAM TOXICOLOGY CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 26, 1983 | K831738 | CAFFINE TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 26, 1983 | K831735 | MAPROTILINE | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 26, 1983 | K831734 | AMOXAPINE 8-HYDRO-XYAMOXAPINE | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 19, 1983 | K831737 | TRICYCLIC ANTIDEPRESSNATS VI | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 6, 1983 | K831740 | DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| July 6, 1983 | K831739 | PENTOBARBITAL TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| February 4, 1981 | K810201 | TOXICOLOGY CONTROL | LAS | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| May 2, 1980 | K800888 | TRICYCLIC ANTIDEPRESSANTS I TX CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800889 | TRICYCLIC ANTIDEPRESSANT II TX CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800887 | HYPNOTICS PLUS SALICYLATE TX CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800886 | HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800885 | BARBITURATES TOXICOLOGY CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800884 | CARDIACS II TOXICOLOGY CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800883 | CARDIACS I TOXICOLOGY CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800882 | ANTICONVULSANTS TOXICOLOGY CONTROL | DIF | Substantially Equivalent | Utak Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 20, 2020 | 85660 | Class III | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Drug Specific Control Materials
- All makers of Drug Mixture Control Materials
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
Updated November 2, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.