The following data is part of a premarket notification filed by Immunicon Corp. with the FDA for Celltracks Analyzer Ii.
| Device ID | K060110 |
| 510k Number | K060110 |
| Device Name: | CELLTRACKS ANALYZER II |
| Classification | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Applicant | IMMUNICON CORP. 3401 MASONS MILL RD. STE 100 Huntingdon Valley, PA 19006 -3574 |
| Contact | Peter Scott |
| Correspondent | Peter Scott IMMUNICON CORP. 3401 MASONS MILL RD. STE 100 Huntingdon Valley, PA 19006 -3574 |
| Product Code | NQI |
| CFR Regulation Number | 866.6020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-17 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CELLTRACKS ANALYZER II 88327580 not registered Live/Pending |
Menarini Silicon Biosystems S.p.A. 2019-03-06 |
![]() CELLTRACKS ANALYZER II 78938240 3409217 Dead/Cancelled |
JOHNSON & JOHNSON 2006-07-26 |
![]() CELLTRACKS ANALYZER II 78566619 not registered Dead/Abandoned |
Immunivest Corporation 2005-02-14 |