Chem-Elec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K943503CHEMCARD GLUCOSE TESTJuly 23, 1996
K864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODJune 10, 1988
K811381ASTRAAugust 13, 1981
K811319CHLORIDE REAGENT KITAugust 13, 1981
K811165GLUCOSE OXIDASE RATE REAGENTAugust 13, 1981
K811406CREATININE RATE REAGENT KITAugust 13, 1981
K811193BUN RATE REAGENTJuly 10, 1981
K811310SODIUM/POTASSIUM REAGENT KITSJuly 10, 1981
K811701CHLORIDE/CARBON DIOXIDE RATE REAGENTJuly 1, 1981