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 |