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 K103116
Device Name AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Bestgen Biotech Corp.
7f, No 186, Jian-Yi Rd.
Jung-He, Taipei County,  TW 235
Applicant Contact STEVEN SHEN
Correspondent
Bestgen Biotech Corp.
7f, No 186, Jian-Yi Rd.
Jung-He, Taipei County,  TW 235
Correspondent Contact STEVEN SHEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received10/21/2010
Decision Date 03/13/2012
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
Predetermined Change
Control Plan Authorized		 No
-
-