Applied BioCode, Inc.

FDA Regulatory Profile

Applied BioCode, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 1, 2026.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254139BioCode® Respiratory Pathogen Panel (RPP)May 1, 2026
K242877BioCode Gastrointestinal Pathogen Panel (GPP)January 10, 2025
K192485BioCode Respiratory Pathogen Panel (RPP)December 23, 2019
K190585Biocode Gastrointestinal Pathogen Panel (GPP)June 5, 2019
K180041BioCode Gastrointestinal Pathogen Panel (GPP)September 28, 2018