510(k) Report

FDA applicant

Mec Dynamics Corp

Santa Clara, CA4 decisions2009–20130 recalls

FDA records 4 decisions for Mec Dynamics Corp (Santa Clara, CA) from 2009 to 2013: 4 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and GKR (System, Hemoglobin, Automated). Its devices cite 3 predicates, 1 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, hematology panel, where it files most

How often FDA has decided Mec Dynamics Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 22011: 12013: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Mec Dynamics Corp by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin3decisions
  • GKRSystem, Hemoglobin, Automated1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091400Modification to Avie A1C Test SystemMec Dynamics Corp · 20091cites it

What has FDA decided for it lately?

  • K121752Avie Total HB Test SystemMec Dynamics Corp · 2013
  • K093548Avie A1C Test SystemMec Dynamics Corp · 2011
  • K091400Modification to Avie A1C Test SystemMec Dynamics Corp · 2009
  • K081269Avie A1C Test SystemMec Dynamics Corp · 2009

All 4 as Mec Dynamics Corp →