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 Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
510(k) Number K223433
Device Name Quantra QPlus System
Applicant
Hemosonics, LLC
4020 Stirrup Creek Dr.
Suite 105
Durham,  NC  27703
Applicant Contact Deborah Winegar
Correspondent
Hemosonics, LLC
4020 Stirrup Creek Dr.
Suite 105
Durham,  NC  27703
Correspondent Contact Deborah Winegar
Classification Product Code
QFR  
Date Received11/14/2022
Decision Date 12/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-