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

Applied BioCode, Inc. is an in-vitro diagnostics manufacturer specializing in multiplex testing products. The company designs, develops, and commercializes syndromic panel assays using proprietary Barcoded Magnetic Bead technology. Applied BioCode operates with a manufacturing facility in Santa Fe Springs, California.

The company has received 5 FDA 510(k) clearances from 5 total submissions since 2018. All submissions focus on Microbiology devices, reflecting the company's core expertise in pathogen detection. The latest clearance in 2026 demonstrates continued regulatory activity and product innovation.

Applied BioCode's cleared portfolio includes respiratory and gastrointestinal pathogen panels compatible with multiple nucleic acid extraction platforms. The company also offers research-use-only products for sexually transmitted infection detection and fungal pathogen identification. High-throughput capabilities enable processing of up to 188 patient samples per shift using 96-well format systems.

Explore the complete list of device names, product codes, and FDA 510(k) clearance dates in the regulatory database.