Company ยท US
Utak Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1991. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 1991 | K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Oct 6, 1988 | K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL Utak Laboratories, Inc. | JJY |
| Nov 13, 1986 | K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Nov 13, 1986 | K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Nov 5, 1986 | K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Aug 4, 1986 | K862420 | UTAK-STABBS TOXICOLOGY CONTROL Utak Laboratories, Inc. | JJY |
| Jul 28, 1983 | K831736 | TRICYCLIC ANTIDEPRESSANTS Utak Laboratories, Inc. | DIF |
| Jul 26, 1983 | K831741 | FLURAZEPAM TOXICOLOGY CONTROL Utak Laboratories, Inc. | DIF |
| Jul 26, 1983 | K831738 | CAFFINE TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Jul 26, 1983 | K831735 | MAPROTILINE Utak Laboratories, Inc. | LAS |
| Jul 26, 1983 | K831734 | AMOXAPINE 8-HYDRO-XYAMOXAPINE Utak Laboratories, Inc. | DIF |
| Jul 19, 1983 | K831737 | TRICYCLIC ANTIDEPRESSNATS VI Utak Laboratories, Inc. | DIF |
| Jul 6, 1983 | K831740 | DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE Utak Laboratories, Inc. | DIF |
| Jul 6, 1983 | K831739 | PENTOBARBITAL TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Feb 4, 1981 | K810201 | TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| May 2, 1980 | K800888 | TRICYCLIC ANTIDEPRESSANTS I TX CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800889 | TRICYCLIC ANTIDEPRESSANT II TX CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800887 | HYPNOTICS PLUS SALICYLATE TX CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800886 | HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800885 | BARBITURATES TOXICOLOGY CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800884 | CARDIACS II TOXICOLOGY CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800883 | CARDIACS I TOXICOLOGY CONTROL Utak Laboratories, Inc. | DIF |
| Apr 29, 1980 | K800882 | ANTICONVULSANTS TOXICOLOGY CONTROL Utak Laboratories, Inc. | DIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2020 | Utak Laboratories Inc 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. Terminated |
JJY | K883147 |