510(k) Report

FDA applicant

General Atomics

Poway, CA6 decisions2003–20090 recalls

FDA records 6 decisions for General Atomics (Poway, CA) from 2003 to 2009: 6 510(k) clearances. Most are in product codes MSJ (Apolipoproteins) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2009

2008: 22009: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — General Atomics 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?

  • MSJApolipoproteins1decision
  • LCPAssay, Glycosylated Hemoglobin1decision
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision
  • DFCLipoprotein, Low-Density, Antigen, Antiserum, Control1decision
  • JIIAtomic Absorption, Lithium1decision
  • LBRLdl & Vldl Precipitation, Hdl1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K082488Diazyme LP (a) AssayGeneral Atomics · 20092cite it
  • K042448Diazyme Homocysteine Enzymatic Assay KitGeneral Atomics · 20041cites it

What has FDA decided for it lately?

  • K082488Diazyme LP (a) AssayGeneral Atomics · 2009
  • K072977Diazyme Apolipoprotein a-1 AssayGeneral Atomics · 2008
  • K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics · 2008
  • K050178HBA1C Enzymatic AssayGeneral Atomics · 2005
  • K042448Diazyme Homocysteine Enzymatic Assay KitGeneral Atomics · 2004
  • K033360Diazyme Lithium Enzymatic Assay KitGeneral Atomics · 2003

All 6 as General Atomics →