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Abx Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030799MICROS 60April 8, 2003
K030144MODIFICATION TO PENTRA 60 AND PENTRA 60C+January 31, 2003
K024002PENTRA 80January 3, 2003
K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120July 29, 2002
K014203ABX MICROS 60 HEMATOLOGY ANALYZERFebruary 28, 2002
K003677ABX PENTRA 60C+ HEMATOLOGY ANALYZERDecember 26, 2000
K002646ABX MICROS CRPOctober 26, 2000
K992511ABX PENTRA 60 HEMATOLOGY ANALYZEROctober 15, 1999
K991839ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZERAugust 11, 1999
K990311VEGA RETIC AUTOMATED HEMATOLOGY ANALYZERMarch 31, 1999