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Diagnostic Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONJanuary 11, 1994
K924398UNI-CHECK REAGENT STRIPDecember 23, 1992
K921825QUICK-CHECK II REAGENT STRIPAugust 18, 1992
K800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-May 30, 1980
K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMMay 30, 1980
K800692REAGENT FOR DETERM. POTASSIUM/IN HUMANMay 28, 1980
K800676REAGENTS FOR DETERM. SODIUM IN HUMAN SUMMay 28, 1980
K800674SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SERMay 28, 1980
K800684REAGENT FOR DETERM. CREATINE PHOSPHOKINAMay 28, 1980
K800673SMAC REPLACEMENT REAGENTS/OF BUN-SERUMMay 28, 1980
K800691REAGENT FOR DETERM. LACTATE/DEHYDROGENASMay 28, 1980
K800686REAGENT FOR DETERM. DIRECT BILIRUBINMay 28, 1980
K800680REAGENTS FOR DETERM. CALCIUM IN HUMANMay 28, 1980
K800682REAGENTS FOR DETERM. CHOLESTEROL/SERUMMay 28, 1980
K800679REAGENTS FOR DETERM. ALKALINE PHOSPHATASMay 28, 1980
K800687REAGENT FOR DETERM. GLUCOSE IN H/SERUMMay 28, 1980
K800683REAGENT FOR DETERM. CHLORIDE IN HUMAN/SMMay 28, 1980
K800672SMAC REPLACEMENT REAGENTS/DETERM-URIC-ACMay 28, 1980
K800688REAGENT FOR DETERM. GLUTAMIC-OXALOACETICMay 28, 1980
K800675REAGENTS FOR DETERM. TOTAL BILIRUBINMay 28, 1980