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 Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K140083
Device Name VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Applicant Contact Teresa Raich
Correspondent
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Correspondent Contact Teresa Raich
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Codes
OOI   PCI  
Date Received01/13/2014
Decision Date 06/20/2014
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
-
-