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 K220062
Device Name QIAstat-Dx Gastrointestinal Panel 2
Applicant
Qiagen GmbH
Qiagen Strasse 1
Hiden,  DE 40724
Applicant Contact Stephany Foster Spahr
Correspondent
Qiagen Manchester, Ltd.
City Labs 2.0
200 Hathersage Rd.
Manchester,  GB M13 0BH
Correspondent Contact Selina Salthouse
Regulation Number866.3990
Classification Product Code
PCH  
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
Predetermined Change
Control Plan Authorized		 No
-
-