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Utak Laboratories Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2407-2020Class IIIUtak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LAMarch 20, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K903061UTAK LABORATORIES TOXICOLOGY CONTROLApril 12, 1991
K883147TRACE ELEMENTS SERUM TOXICOLOGY CONTROLOctober 6, 1988
K862419SERUM VANCOMYCIN TOXICOLOGY CONTROLNovember 13, 1986
K862418BENZODIAZEPINES TOXICOLOGY CONTROLNovember 13, 1986
K862421SERUM CLONAZEPAM TOXICOLOGY CONTROLNovember 5, 1986
K862420UTAK-STABBS TOXICOLOGY CONTROLAugust 4, 1986
K831736TRICYCLIC ANTIDEPRESSANTSJuly 28, 1983
K831735MAPROTILINEJuly 26, 1983
K831734AMOXAPINE 8-HYDRO-XYAMOXAPINEJuly 26, 1983
K831738CAFFINE TOXICOLOGY CONTROLJuly 26, 1983
K831741FLURAZEPAM TOXICOLOGY CONTROLJuly 26, 1983
K831737TRICYCLIC ANTIDEPRESSNATS VIJuly 19, 1983
K831739PENTOBARBITAL TOXICOLOGY CONTROLJuly 6, 1983
K831740DISOPYRAMIDE N-DESALKYLDISOPYRAMIDEJuly 6, 1983
K810201TOXICOLOGY CONTROLFebruary 4, 1981
K800888TRICYCLIC ANTIDEPRESSANTS I TX CONTROLMay 2, 1980
K800884CARDIACS II TOXICOLOGY CONTROLApril 29, 1980
K800889TRICYCLIC ANTIDEPRESSANT II TX CONTROLApril 29, 1980
K800882ANTICONVULSANTS TOXICOLOGY CONTROLApril 29, 1980
K800883CARDIACS I TOXICOLOGY CONTROLApril 29, 1980