The following data is part of a premarket notification filed by Cell Analysis, Inc. with the FDA for Qca (version 3.1).
| Device ID | K031363 |
| 510k Number | K031363 |
| Device Name: | QCA (VERSION 3.1) |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | CELL ANALYSIS, INC. 1801 MAPLE AVENUE SUTIE 2319 Evanston, IL 60202 |
| Contact | Joel Herm |
| Correspondent | Joel Herm CELL ANALYSIS, INC. 1801 MAPLE AVENUE SUTIE 2319 Evanston, IL 60202 |
| Product Code | NQN |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2004-02-05 |
| Summary: | summary |