CELLTRACKS AUTOPREP SYSTEM
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
VERIDEX, LLC
The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Celltracks Autoprep System.
Pre-market Notification Details
| Device ID | K122821 |
| 510k Number | K122821 |
| Device Name: | CELLTRACKS AUTOPREP SYSTEM |
| Classification | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Applicant | VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Contact | Kimberly Prescott |
| Correspondent | Kimberly Prescott VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Product Code | NQI |
| CFR Regulation Number | 866.6020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-14 |
| Decision Date | 2012-12-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888385000665 | K122821 | 000 |
Trademark Results [CELLTRACKS AUTOPREP SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLTRACKS AUTOPREP SYSTEM 78194378 2865714 Live/Registered |
JOHNSON & JOHNSON 2002-12-13 |
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