• 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 c. difficile toxin gene amplification assay
510(k) Number K123197
Device Name VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
northbrook,  IL  60062
Applicant Contact mark del vecchio
Correspondent
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
northbrook,  IL  60062
Correspondent Contact mark del vecchio
Regulation Number866.3130
Classification Product Code
OZN  
Date Received10/11/2012
Decision Date 12/05/2012
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
Recalls CDRH Recalls
-
-