• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name drug metabolizing enzyme genotyping systems
510(k) Number K120466
Device Name VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
Original Applicant
NANOSPHERE, INC
4088 commercial avenue
northbrook,  IL  60062
Original Contact mark del vecchio
Regulation Number862.3360
Classification Product Code
NTI  
Subsequent Product Code
NSU  
Date Received02/15/2012
Decision Date 11/06/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-