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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K242877
Device Name BioCode Gastrointestinal Pathogen Panel (GPP)
Applicant
Applied BioCode, Inc.
12130 Mora Drive
Unit 2
Santa Fe Springs,  CA  90670
Applicant Contact Alex Chang
Correspondent
Applied BioCode, Inc.
12130 Mora Drive
Unit 2
Santa Fe Springs,  CA  90670
Correspondent Contact Alex Chang
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received09/23/2024
Decision Date 01/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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