510(k) Report

FDA applicant

Abx Diagnostics

Irvine, CA10 decisions1999–20037 recalls

FDA records 10 decisions for Abx Diagnostics (Irvine, CA) from 1999 to 2003: 10 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and GKX (Instrument, Automated Platelet Counting). Its devices cite 17 predicates, 8 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Abx Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Abx Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Abx Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GKZCounter, Differential Cell9decisions
  • GKXInstrument, Automated Platelet Counting1decision

Whose devices does it build on?

Its devices cite 17 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K990311Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 19994cite it
  • K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 19993cite it
  • K992511Abx Pentra 60 Hematology AnalyzerAbx Diagnostics · 19992cite it
  • K003677Abx Pentra 60C+ Hematology AnalyzerAbx Diagnostics · 20002cite it
  • K002646Abx Micros CRPAbx Diagnostics · 20002cite it
  • K024002Pentra 80Abx Diagnostics · 20031cites it

What has FDA decided for it lately?

  • K030799Micros 60Abx Diagnostics · 2003
  • K030144Modification to Pentra 60 and Pentra 60C+Abx Diagnostics · 2003
  • K024002Pentra 80Abx Diagnostics · 20032 recalls
  • K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 20022 recalls
  • K014203Abx Micros 60 Hematology AnalyzerAbx Diagnostics · 2002
  • K003677Abx Pentra 60C+ Hematology AnalyzerAbx Diagnostics · 20002 recalls
  • K002646Abx Micros CRPAbx Diagnostics · 2000
  • K992511Abx Pentra 60 Hematology AnalyzerAbx Diagnostics · 19991 recall

All 10 as Abx Diagnostics →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K022200ABX Pentra 120,120R,120DX, automated hematology analyzerMar 24, 2006
  • K024002Automated Differential Cell CounterAug 13, 2004
  • K024002Automated Differential Cell CounterAug 13, 2004
  • K022200PENTRA 120 and PENTRA 120 Retic Hematology AnalyzerJun 24, 2004
  • K992511Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604Sep 8, 2003
  • K003677ABX Diagnostices Pentra 60C+ Hematology AnalyzerJun 4, 2003