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 K141133
Device Name VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
Applicant
BIOMERIEUX
595 ANGLUM ROAD
HAZELWOOD,  MO  63042 -2320
Applicant Contact JOHN ALBRIGHT
Correspondent
BIOMERIEUX
595 ANGLUM ROAD
HAZELWOOD,  MO  63042 -2320
Correspondent Contact JOHN ALBRIGHT
Regulation Number866.3110
Classification Product Code
LYR  
Subsequent Product Codes
CDZ   DAP   JHI   JJE   JLW  
KLI   LFX   LGD   LSR  
Date Received05/01/2014
Decision Date 07/09/2015
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
Recalls CDRH Recalls
-
-