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Pointe Scientific, Inc.,

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
74
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K070757MICROPROTEIN REAGENT SETDecember 4, 2007
K062118POINTE 360July 13, 2007
K070251CARBON DIOXIDE LIQUID STABLE REAGENTApril 30, 2007
K070207MULTI-ANALYTE CHEMISTRY CALIBRATORApril 13, 2007
K070504AMMONIA/ALCOHOL CONTROL SETApril 11, 2007
K061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSMarch 28, 2007
K051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGHOctober 7, 2005
K040391TOTAL BILIRUBIN REAGENT SETJune 2, 2004
K031539HEMOGLOBIN A1C REAGENT SETAugust 6, 2003
K023860MICROALBUMIN REAGENT SET AND CALIBRATORSApril 28, 2003
K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEMarch 31, 2003
K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)December 23, 2002
K002199MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SETNovember 20, 2000
K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETOctober 13, 2000
K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETDecember 21, 1999
K992002AUTOHDL CHOLESTEROL REAGENT SETAugust 5, 1999
K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORJuly 22, 1998
K973588LIQUID ALKALINE PHOSHATASE REAGENT SETOctober 22, 1997
K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETOctober 10, 1997
K973589LIQUID LDH-L REAGENT SETOctober 8, 1997