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, Test, Blood Glucose, Over The Counter
510(k) Number K140068
Device Name CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
Applicant
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis,  IN  46268
Applicant Contact MARGO ENRIGHT
Correspondent
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis,  IN  46268
Correspondent Contact MARGO ENRIGHT
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   CHH   JGY   LBR  
Date Received01/13/2014
Decision Date 05/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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
-
-