The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Celltracks Analyer Ii.
| Device ID | K113181 |
| 510k Number | K113181 |
| Device Name: | CELLTRACKS ANALYER II |
| Classification | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Applicant | VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Contact | Patricia Hojnoski |
| Correspondent | Patricia Hojnoski 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 | 2011-10-28 |
| Decision Date | 2011-12-12 |
| Summary: | summary |