Livonia Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K852161SERUM IRON/VIBC REAGENT SETJune 10, 1985
K844322SGOT REAGENT SETNovember 27, 1984
K844283SGPT REAGENT SETNovember 27, 1984
K844237ALKALINE PHOSPHATASE REAGENT SETNovember 20, 1984
K844156UREA NITROGEN REAGENT SETNovember 13, 1984
K844182INORGANIC PHOSPHORUS REAGENT SETNovember 9, 1984
K843894HDL PRECIPATATING REAGENT SETNovember 2, 1984
K843893MAGNESIUM REAGENT SETOctober 30, 1984
K844075URIC ACID REAGENT SETOctober 30, 1984
K844024CREATININE REAGENT SETOctober 30, 1984
K843895TOTAL CALCIUM REAGENT SETOctober 30, 1984
K843831ALBUMIN REAGENT SETOctober 11, 1984
K843701TOTAL PROTEIN REAGENT SETOctober 1, 1984
K843528GLUCOSE OXIDASE ENZYMATIC REAGENT SETSeptember 28, 1984
K843222ENZYMATIC CHOLESTEROL KITSeptember 28, 1984
K842368SICKLE CELL REAGENT SETJuly 20, 1984