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 K050145
Device Name CELLTRACKA ANALYZER II
Applicant
IMMUNICON CORP.
3401 MASONS MILL RD. STE 100
HUNTINGDON VALLEY,  PA  19006 -3574
Applicant Contact PETER SCOTT
Correspondent
IMMUNICON CORP.
3401 MASONS MILL RD. STE 100
HUNTINGDON VALLEY,  PA  19006 -3574
Correspondent Contact PETER SCOTT
Regulation Number866.6020
Classification Product Code
NQI  
Date Received01/24/2005
Decision Date 03/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-