510(k) Report

FDA applicant

Idaho Technology, Inc.

Salt Lake City, UT8 decisions2005–20120 recalls

FDA records 8 decisions for Idaho Technology, Inc. (Salt Lake City, UT) from 2005 to 2012: 8 510(k) clearances. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and NHT (Assay, Nucleic Acid Amplification, Bacillus…). Its devices cite 14 predicates, 3 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, microbiology panel, where it files most

How often FDA has decided Idaho Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 32011: 32012: 1
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Idaho Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OCCRespiratory Virus Panel Nucleic Acid Assay System3decisions
  • NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis3decisions
  • OEHJoint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection…1decision
  • OVFAssay, Direct, Nucleic Acid Amplification, Q Fever1decision

Whose devices does it build on?

Its devices cite 14 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 3 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.

  • K103175Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 20115cite it
  • K110764Filmarray RP PanelIdaho Technology, Inc. · 20114cite it
  • K120267Filmarray RP PanelIdaho Technology, Inc. · 20124cite it
  • K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 20053cite it
  • K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 20072cite it
  • K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 20071cites it

What has FDA decided for it lately?

  • K120267Filmarray RP PanelIdaho Technology, Inc. · 2012
  • K103207Jbaids Q Fever Detection KitIdaho Technology, Inc. · 2011
  • K110764Filmarray RP PanelIdaho Technology, Inc. · 2011
  • K103175Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
  • K072631Jbaids Plaque Detection Kit, Model JRPD-Asy-0123Idaho Technology, Inc. · 2007
  • K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 2007
  • K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007
  • K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005

All 8 as Idaho Technology, Inc. →