The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Celltracks Analyzer Ii System.
| Device ID | K130794 |
| 510k Number | K130794 |
| Device Name: | CELLTRACKS ANALYZER II 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-22 |
| Decision Date | 2013-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888385000658 | K130794 | 000 |