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, Immunomagnetic, Circulating Cancer Cell, Enumeration
510(k) Number K122821
Device Name CELLTRACKS AUTOPREP SYSTEM
Applicant
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN,  NJ  08869 -0606
Applicant Contact KIMBERLY PRESCOTT
Correspondent
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN,  NJ  08869 -0606
Correspondent Contact KIMBERLY PRESCOTT
Regulation Number866.6020
Classification Product Code
NQI  
Date Received09/14/2012
Decision Date 12/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-