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 Assay, Heparin
510(k) Number K162540
Device Name INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
Applicant
Siemens Healthcare Diagnostics Prodcts GmbH
Emil-Von Behring St. 76
Marburg,  DE 35041
Applicant Contact ROSE T MARINELLI
Correspondent
Siemens Healthcare Diagnostics Prodcts GmbH
Emil-Von Behring St. 76
Marburg,  DE 35041
Correspondent Contact ROSE T MARINELLI
Regulation Number864.7525
Classification Product Code
KFF  
Subsequent Product Codes
GGN   JIS  
Date Received09/12/2016
Decision Date 08/22/2017
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
-
-