The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for 900udx Urine Pathology System.
| Device ID | K960054 |
| 510k Number | K960054 |
| Device Name: | 900UDX URINE PATHOLOGY SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Alan E Koontz, Ph.d. |
| Correspondent | Alan E Koontz, Ph.d. 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 | 1996-01-04 |
| Decision Date | 1996-03-22 |
| Summary: | summary |