THE YELLOW IRIS
Automated Urinalysis System
INTL. REMOTE IMAGING SYSTEMS
The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for The Yellow Iris.
Pre-market Notification Details
| Device ID | K943463 |
| 510k Number | K943463 |
| Device Name: | THE YELLOW IRIS |
| Classification | Automated Urinalysis System |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Sanford Widran |
| Correspondent | Sanford Widran INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1994-09-20 |
Trademark Results [THE YELLOW IRIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE YELLOW IRIS 73572499 1422605 Dead/Cancelled |
INTERNATIONAL REMOTE IMAGING SYSTEMS 1985-12-09 |
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