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 K110571
Device Name TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
Applicant
TELCARE, INC.
3 BETHESDA METRO CENTER
SUITE 430
BETHESDA,  MD  20814
Applicant Contact JONATHAN C JAVITT
Correspondent
TELCARE, INC.
3 BETHESDA METRO CENTER
SUITE 430
BETHESDA,  MD  20814
Correspondent Contact JONATHAN C JAVITT
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX   JQP  
Date Received03/01/2011
Decision Date 07/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-