# Applied BioCode, Inc.

- Location (FDA's records): Santa Fe Springs, CA
- FDA decisions: 5 (2018–2026): 5 510(k) clearances
- Product codes: PCH (3), OCC (2)
- 510(k) review time since 2016: median 109 days, against 105 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Diagnostics, LLC: 1 (https://510kreport.com/company/biofire-diagnostics)
- Luminex Molecular Diagnostics, Inc.: 1 (https://510kreport.com/company/luminex-molecular-diagnostics)

## Its most-cited devices
- K192485: BioCode Respiratory Pathogen Panel (RPP) (2019), cited by 1
- K180041: BioCode Gastrointestinal Pathogen Panel (GPP) (2018), cited by 1
- K190585: Biocode Gastrointestinal Pathogen Panel (GPP) (2019), cited by 1

## Recent decisions
- K254139: BioCode® Respiratory Pathogen Panel (RPP) (May 1, 2026)
- K242877: BioCode Gastrointestinal Pathogen Panel (GPP) (Jan 10, 2025)
- K192485: BioCode Respiratory Pathogen Panel (RPP) (Dec 23, 2019)
- K190585: Biocode Gastrointestinal Pathogen Panel (GPP) (Jun 5, 2019)
- K180041: BioCode Gastrointestinal Pathogen Panel (GPP) (Sep 28, 2018)

Source page: https://510kreport.com/company/applied-biocode