Company ยท US
Abx Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2003. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 8, 2003 | K030799 | MICROS 60 Abx Diagnostics, FR | GKZ |
| Jan 31, 2003 | K030144 | MODIFICATION TO PENTRA 60 AND PENTRA 60C+ Abx Diagnostics, FR | GKZ |
| Jan 3, 2003 | K024002 | PENTRA 80 Abx Diagnostics, FR | GKZ |
| Jul 29, 2002 | K022200 | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 Abx Diagnostics, FR | GKZ |
| Feb 28, 2002 | K014203 | ABX MICROS 60 HEMATOLOGY ANALYZER Abx Diagnostics | GKX |
| Dec 26, 2000 | K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Oct 26, 2000 | K002646 | ABX MICROS CRP Abx Diagnostics | GKZ |
| Oct 15, 1999 | K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Aug 11, 1999 | K991839 | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
| Mar 31, 1999 | K990311 | VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER Abx Diagnostics | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2006 | ABX Diagnostics Inc ABX Pentra 120,120R,120DX, automated hematology analyzer Terminated |
GKZ | K022200 K050719 |
| Dec 23, 2005 | ABX Diagnostics Inc Pentra 80 and Pentra 80XL Hematology Analyzers Terminated |
GKZ | None listed |
| Oct 5, 2004 | ABX Diagnostics Inc Automated Differential Cell Counter Terminated |
GKZ | K024002 |
| Oct 5, 2004 | ABX Diagnostics Inc Automated Differential Cell Counter Terminated |
GKZ | K024002 |
| Aug 13, 2004 | ABX Diagnostics Inc PENTRA 120 and PENTRA 120 Retic Hematology Analyzer Terminated |
GJH | K022200 |
| Aug 21, 2003 | ABX Diagnostics Inc ABX Diagnostices Pentra 60C+ Hematology Analyzer Terminated |
GKZ | K003677 |