The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Celltracks Autoprep System Model:9541.
| Device ID | K100684 |
| 510k Number | K100684 |
| Device Name: | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 |
| Classification | Apparatus, Automated Blood Cell Diluting |
| Applicant | VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Contact | Sarah Mcmanus |
| Correspondent | Sarah Mcmanus VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan, NJ 08869 -0606 |
| Product Code | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-08-26 |
| Summary: | summary |