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 glucose oxidase, glucose
510(k) Number K952279
Device Name PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM
Applicant
MEDISENSE, INC.
266 SECOND AVE.
WALTHAM,  MA  02154
Applicant Contact MICHAEL HALPIN
Correspondent
MEDISENSE, INC.
266 SECOND AVE.
WALTHAM,  MA  02154
Correspondent Contact MICHAEL HALPIN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/11/1995
Decision Date 06/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-