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 Helicobacter Pylori
510(k) Number K183573
Device Name Vstrip H. pylori Antigen Rapid Test
Applicant
Panion & BF Biotech, Inc.
6f.-3, #306, Sec. 1, Datong Rd., Xizhi Dist.
New Taipei City,  TW 22146
Applicant Contact Ching Sui A. Yi
Correspondent
Amarex Clinical Research, LLC
20201 Century Blvd., Fourth Floor
Germantown,  MD  20874
Correspondent Contact Kazem Kazempour
Regulation Number866.3110
Classification Product Code
LYR  
Date Received12/21/2018
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-