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 Test, Time, Prothrombin
510(k) Number K180684
Device Name CoaguChek XS Plus System
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Bin Sun
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Bin Sun
Regulation Number864.7750
Classification Product Code
GJS  
Date Received03/15/2018
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-