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Gds Diagnostics

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K931257ACETASITEJuly 8, 1993
K910881CONTROL AND LINEARITYSeptember 13, 1991
K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDMarch 4, 1991
K891761GDS ENZYMATIC THEOPHYLLINE REAGENTMay 16, 1989