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 K090043
Device Name AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
Applicant
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Applicant Contact THOMAS Y.S. SHEN
Correspondent
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Correspondent Contact THOMAS Y.S. SHEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received01/07/2009
Decision Date 04/09/2009
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
-
-