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 Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name kit, quality control for blood banking reagents
510(k) Number BK170064
Tradename IH-Internal QC
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Bio-Rad Medical Diagnostics GmbH
industriestrasse 1
dreieich,  63303,  GERMANY
Regulation Number864.9650
Classification Product Code
KSF  
Date Received06/19/2017
Decision Date 12/18/2017
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-