Abx Diagnostics is one of 13055 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Abx Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: ABX PENTRA 60 HEMATOLOGY ANALYZER, ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER, VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
10
Total
10
Cleared
0
Denied
Abx Diagnostics has 10 FDA 510(k) cleared hematology devices. Based in Irvine, US.
Historical record: 10 cleared submissions from 1999 to 2003.
Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Abx Diagnostics
10 devices
Cleared
Apr 08, 2003
MICROS 60
Hematology
26d
Cleared
Jan 31, 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
Hematology
16d
Cleared
Jan 03, 2003
PENTRA 80
Hematology
30d
Cleared
Jul 29, 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
Hematology
24d
Cleared
Feb 28, 2002
ABX MICROS 60 HEMATOLOGY ANALYZER
Hematology
69d
Cleared
Dec 26, 2000
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
Hematology
27d
Cleared
Oct 26, 2000
ABX MICROS CRP
Hematology
63d
Cleared
Oct 15, 1999
ABX PENTRA 60 HEMATOLOGY ANALYZER
Hematology
80d
Cleared
Aug 11, 1999
ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
Hematology
75d
Cleared
Mar 31, 1999
VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
Hematology
58d