The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for The Purple Iris(tm) Cytopathology Workstation.
| Device ID | K874207 |
| 510k Number | K874207 |
| Device Name: | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION |
| Classification | Light, Microscope |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Kasden, Phd |
| Correspondent | Kasden, Phd INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Product Code | IBJ |
| CFR Regulation Number | 864.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-15 |
| Decision Date | 1988-01-05 |