Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-