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 Real Time Nucleic Acid Amplification System
510(k) Number K140447
Device Name BD VIPER LT SYSTEM
Applicant
Becton, Dickinson and Company
7 LOVETON CIRCLE
SPARKS,  MD  21152
Applicant Contact SHERMA WINSTON
Correspondent
Becton, Dickinson and Company
7 LOVETON CIRCLE
SPARKS,  MD  21152
Correspondent Contact SHERMA WINSTON
Regulation Number862.2570
Classification Product Code
OOI  
Date Received02/21/2014
Decision Date 05/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-