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 System, Hemoglobin, Automated
510(k) Number K201217
Device Name HemoCue Hb 301 System
Applicant
Hemocue AB
Kuvettgatan 1
Ängelholm,  SE 26271
Applicant Contact Maria Fagerberg
Correspondent
Hemocue AB
Kuvettgatan 1
Ängelholm,  SE 26271
Correspondent Contact Maria Fagerberg
Regulation Number864.5620
Classification Product Code
GKR  
Date Received05/06/2020
Decision Date 08/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-