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 Hexokinase, Glucose
510(k) Number K060383
Device Name GLUCOSE
Applicant
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
Abbott Laboratories
1921 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.1345
Classification Product Code
CFR  
Date Received02/14/2006
Decision Date 05/05/2006
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
-
-