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Gilford Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
50
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K832094BILIRUBIN CALIBRATORS & CONTROLAugust 11, 1983
K831844DIRECT BILIRUBIN REAGENTJuly 18, 1983
K831843GILCHEM TOTAL BILIRUBIN REAGENTJuly 18, 1983
K823709TRIGLYCERIDE REAGENT (UV)January 7, 1983
K822739AHBDOctober 18, 1982
K822334BILIRUBIN CALIBRATORSSeptember 2, 1982
K822289CO2/CI STANDARDSAugust 24, 1982
K822149GILCHEM Y-GT REAGENTAugust 12, 1982
K821719AMMONIA REAGENTJune 24, 1982
K820975GILCHEM ACID PHOSPHATASE REAGENTApril 26, 1982
K820976GIL CHEM MAGNESIUM REAGENTApril 26, 1982
K813478TRIGLYCERIDE CALIBRATORSDecember 22, 1981
K812912GILCHEM ALP REAGENTNovember 2, 1981
K812861CHOLESTEROL CALIBRATORSOctober 23, 1981
K812109GILCHEM CREATININE REAGENTAugust 13, 1981
K812110GILCHEM CALCIUM REAGENTAugust 13, 1981
K811886CESIUM DILUENT 7.5MJuly 23, 1981
K811659CREATININE REAGENTJune 26, 1981
K810405CHOLESTEROL REAGENTFebruary 26, 1981
K803301CREATINE KINASE REAGENTJanuary 16, 1981