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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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