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 K070704
Device Name TRILOGY ANALYZER
Applicant
Drew Scientific, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA SINCLAIR
Correspondent
Drew Scientific, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA SINCLAIR
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CDQ   CEM   CGX   CGZ   JGS  
JJE  
Date Received03/13/2007
Decision Date 07/13/2007
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
-
-