Data / Medical devices / United States / Applied BioCode, Inc.
Applied BioCode, Inc.: FDA-registered device maker in Santa Fe Springs, CA, United States, 5 510(k) clearances
Applied BioCode, Inc. is registered with the FDA (registration 3007799234) in Santa Fe Springs, CA, United States. It lists 15 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007799234
- Address
- 12130 Mora Drive Unit #2, Santa Fe Springs, CA, United States, 90670
- Owner or operator
- Applied BioCode, Inc. (10029149)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 22, 2017
- Registered through
- 2026
- Brand names listed
- BioCode 2500 Multiplex Detection System, BioCode Aspergillus flavus BMB-Probe, BioCode Aspergillus fumigatus BMB-Probe, BioCode Aspergillus niger BMB-Probe, BioCode Aspergillus terreus BMB-Probe, BioCode Blastomyces dermatitidis BMB-Probe, BioCode Candida albicans BMB-Probe, BioCode Candida auris BMB-Probe and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2026 | K254139 | BioCode® Respiratory Pathogen Panel (RPP) | OCC | Substantially Equivalent | Applied BioCode, Inc. | accessdata.fda.gov |
| January 10, 2025 | K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent | Applied BioCode, Inc. | accessdata.fda.gov |
| December 23, 2019 | K192485 | BioCode Respiratory Pathogen Panel (RPP) | OCC | Substantially Equivalent | Applied BioCode, Inc. | accessdata.fda.gov |
| June 5, 2019 | K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent | Applied BioCode, Inc. | accessdata.fda.gov |
| September 28, 2018 | K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent | Applied BioCode, Inc. | accessdata.fda.gov |
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Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.