Device Classification Name |
system, immunomagnetic, circulating cancer cell, enumeration
|
510(k) Number |
K113181 |
Device Name |
CELLTRACKS ANALYER II |
Applicant |
VERIDEX, LLC |
1001 US HIGHWAY 202 NORTH |
RARITAN,
NJ
08869 -0606
|
|
Applicant Contact |
PATRICIA HOJNOSKI |
Correspondent |
VERIDEX, LLC |
1001 US HIGHWAY 202 NORTH |
RARITAN,
NJ
08869 -0606
|
|
Correspondent Contact |
PATRICIA HOJNOSKI |
Regulation Number | 866.6020
|
Classification Product Code |
|
Date Received | 10/28/2011 |
Decision Date | 12/12/2011 |
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
|
|
|