The following data is part of a premarket notification filed by Iris Remote Imaging Systems with the FDA for Pathology Instrumentation & Accessories.
| Device ID | K823040 |
| 510k Number | K823040 |
| Device Name: | PATHOLOGY INSTRUMENTATION & ACCESSORIES |
| Classification | Light, Microscope |
| Applicant | IRIS REMOTE IMAGING SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IBJ |
| CFR Regulation Number | 864.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-14 |
| Decision Date | 1983-01-14 |