Medical Device Manufacturer · US , Santa Fe Springs , CA

Applied BioCode, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

Recent clearances: BioCode® Respiratory Pathogen Panel (RPP), BioCode Gastrointestinal Pathogen Panel (GPP), BioCode Respiratory Pathogen Panel (RPP)

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5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Applied BioCode, Inc. Microbiology ✕

5 devices

1-5 of 5

Cleared May 01, 2026

BioCode® Respiratory Pathogen Panel (RPP)

Microbiology · 130d

Cleared Jan 10, 2025

BioCode Gastrointestinal Pathogen Panel (GPP)

Microbiology · 109d

Cleared Dec 23, 2019

BioCode Respiratory Pathogen Panel (RPP)

Microbiology · 104d

Cleared Jun 05, 2019

Biocode Gastrointestinal Pathogen Panel (GPP)

Microbiology · 91d

Cleared Sep 28, 2018

BioCode Gastrointestinal Pathogen Panel (GPP)

Microbiology · 266d