Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Applied BioCode with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 1, 2026: BioCode® Respiratory Pathogen Panel (RPP).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 1, 2026 | BioCode® Respiratory Pathogen Panel (RPP)K254139 · OCC | 510(k) clearances |
| Jan 10, 2025 | BioCode Gastrointestinal Pathogen Panel (GPP)K242877 · PCH | 510(k) clearances |
| Dec 23, 2019 | BioCode Respiratory Pathogen Panel (RPP)K192485 · OCC | 510(k) clearances |
| Jun 5, 2019 | Biocode Gastrointestinal Pathogen Panel (GPP)K190585 · PCH | 510(k) clearances |
| Sep 28, 2018 | BioCode Gastrointestinal Pathogen Panel (GPP)K180041 · PCH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
