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King Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTOctober 22, 1993
K931834KING SODIUM/POTASSIUM STANDARD MODIFIEDAugust 25, 1993
K931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)August 16, 1993
K931326KING DIAGNOSTICS CK REAGENTJune 15, 1993
K923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTNovember 2, 1992
K922969KING DIAGNOSTICS UREA NITROGEN REAGENTOctober 13, 1992
K922921KING DIAGNOSTICS CHLORIDE REAGENTOctober 5, 1992
K923927KING DIAGNOSTICS MAGNESIUM REAGENTSeptember 30, 1992
K923091KING DIAGNOSTICS GAMMA GT REAGENTSeptember 9, 1992
K923128KING DIAGNOSTICS CHOLESTEROL REAGENTSeptember 9, 1992
K922964KING DIAGNOSTIC TRIGLYCERIDES REAGENTAugust 18, 1992
K922835CALCIUM (AZ III) REAGENTAugust 4, 1992
K922108KING DIAGNOSTICS AST (GOT) REAGENTJuly 15, 1992
K922109KING DIAGNOSTICS ALT (GPT) REAGENTJune 4, 1992
K920809KING DIAGNOSTICS SODIUM/POTASSIUM STANDARDApril 17, 1992
K912499KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TESTSeptember 27, 1991
K912251KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TESTJuly 18, 1991
K884485KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENTDecember 28, 1988
K883635KD 0.1 M SODIUM CITRATE SOLUTIONOctober 31, 1988
K883640KD ONE-STAGE PROTHROMBIN TIME TESTOctober 31, 1988