Idaho Technology, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Idaho Technology, Inc.” (first 2005, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 106 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 3 | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 3 | 3 |
| OEH | Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit | 1 | 1 |
| OVF | Assay, Direct, Nucleic Acid Amplification, Q Fever | 1 | 1 |
Review panels
- Microbiology (8)
Most recent Idaho Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120267 | FILMARRAY RP PANEL | OCC | 2012-05-15 | 106 |
| K103207 | JBAIDS Q FEVER DETECTION KIT | OVF | 2011-05-20 | 200 |
| K110764 | FILMARRAY RP PANEL | OCC | 2011-04-27 | 40 |
| K103175 | FILMARRAY RESPIRATORY PANEL (RP) | OCC | 2011-02-17 | 112 |
| K072631 | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | NHT | 2007-12-20 | 93 |
| K072547 | JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 | OEH | 2007-12-19 | 100 |
| K071188 | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | NHT | 2007-05-21 | 21 |
| K051713 | JBAIDS ANTHRAC DETECTION SYSTEM | NHT | 2005-11-18 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Idaho Technology, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Idaho Technology, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Idaho Technology, Inc.” (first 2005, latest 2012), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Idaho Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Idaho Technology, Inc. is 103 days.
Which FDA product codes appear under Idaho Technology, Inc.?
The most frequent FDA product codes under this applicant name are NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis, 3); OCC (Respiratory Virus Panel Nucleic Acid Assay System, 3); OEH (Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit, 1).
Next steps
- See all 8 Idaho Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHT, Idaho Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.