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 system, test, automated, antimicrobial susceptibility, short incubation
510(k) Number K111976
Device Name VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact JENNIFER CHIA-HSUAN LIN
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact JENNIFER CHIA-HSUAN LIN
Regulation Number866.1645
Classification Product Code
LON  
Date Received07/12/2011
Decision Date 02/17/2012
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
-
-