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 Control, Hemoglobin
510(k) Number K182744
Device Name HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
Applicant
Eurotrol B.V.
Keplerlaan 20
Ede,  NL 6716 BS
Applicant Contact Mylene de Boer
Correspondent
Eurotrol B.V.
Keplerlaan 20
Ede,  NL 6716 BS
Correspondent Contact Mylene de Boer
Regulation Number864.8625
Classification Product Code
GGM  
Date Received09/28/2018
Decision Date 02/01/2019
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
-
-