• 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 K220062
Device Name QIAstat-Dx Gastrointestinal Panel 2
QIAGEN Strasse 1
Hilden,  DE 40724
Applicant Contact Stephany Foster Spahr
QIAGEN Manchester Ltd
CityLabs 2.0, 200 Hathersage Road
Manchester,  GB M13 0BH
Correspondent Contact Selina Salthouse
Regulation Number866.3990
Classification Product Code
Date Received01/10/2022
Decision Date 05/31/2024
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