Utak Laboratories Inc
FDA Regulatory Profile
Utak Laboratories Inc appears in FDA public data with 1 recall, 23 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2407-2020, Class III) was initiated on March 20, 2020. Its most recent 510(k) clearance was granted on April 12, 1991.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 23
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2407-2020 | Class III | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LA | March 20, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL | April 12, 1991 |
| K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL | October 6, 1988 |
| K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL | November 13, 1986 |
| K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL | November 13, 1986 |
| K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL | November 5, 1986 |
| K862420 | UTAK-STABBS TOXICOLOGY CONTROL | August 4, 1986 |
| K831736 | TRICYCLIC ANTIDEPRESSANTS | July 28, 1983 |
| K831734 | AMOXAPINE 8-HYDRO-XYAMOXAPINE | July 26, 1983 |
| K831738 | CAFFINE TOXICOLOGY CONTROL | July 26, 1983 |
| K831741 | FLURAZEPAM TOXICOLOGY CONTROL | July 26, 1983 |
| K831735 | MAPROTILINE | July 26, 1983 |
| K831737 | TRICYCLIC ANTIDEPRESSNATS VI | July 19, 1983 |
| K831740 | DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE | July 6, 1983 |
| K831739 | PENTOBARBITAL TOXICOLOGY CONTROL | July 6, 1983 |
| K810201 | TOXICOLOGY CONTROL | February 4, 1981 |
| K800888 | TRICYCLIC ANTIDEPRESSANTS I TX CONTROL | May 2, 1980 |
| K800887 | HYPNOTICS PLUS SALICYLATE TX CONTROL | April 29, 1980 |
| K800886 | HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL | April 29, 1980 |
| K800884 | CARDIACS II TOXICOLOGY CONTROL | April 29, 1980 |
| K800889 | TRICYCLIC ANTIDEPRESSANT II TX CONTROL | April 29, 1980 |