Diagnostic Specialties

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITSeptember 2, 1997
K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITAugust 30, 1994
K930823PROTEIN-BOUND GLUCOSE ASSAYN KITAugust 19, 1993
K922032ENZIP URINARY MICROALBUMIN TESTJuly 30, 1992
K831180PREGNA-CERT, SLIDE PREGNANCY TESTMay 27, 1983
K823109GENERIC PREGNANCY TESTNovember 10, 1982
K813608POTASSIUM REAGENT SETJanuary 22, 1982
K813412GLUCOSE ENZYME-COLOR REAGENT SETDecember 31, 1981