The following data is part of a premarket notification filed by International Remote Imaging Systems with the FDA for Aution Max Ax-4280 Urinalysis System.
| Device ID | K013783 |
| 510k Number | K013783 |
| Device Name: | AUTION MAX AX-4280 URINALYSIS SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | INTERNATIONAL REMOTE IMAGING SYSTEMS 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m Nolte |
| Correspondent | Cynthia J.m Nolte INTERNATIONAL REMOTE IMAGING SYSTEMS 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-14 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987486001959 | K013783 | 000 |