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 Lynch Syndrome Test System
510(k) Number K211181
Device Name Idylla MSI Test
Applicant
Biocartis NV
Generaal De Wittelaan 11 B3
Mechelen,  BE 2800
Applicant Contact Elnaz Jokar
Correspondent
Biocartis NV
Generaal De Wittelaan 11 B3
Mechelen,  BE 2800
Correspondent Contact Elnaz Jokar
Regulation Number864.1866
Classification Product Code
PZJ  
Date Received04/20/2021
Decision Date 02/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-