The following data is part of a premarket notification filed by International Remote Imaging Systems with the FDA for Aution Jet Aj-4270 Urine Analyzer.
| Device ID | K030600 |
| 510k Number | K030600 |
| Device Name: | AUTION JET AJ-4270 URINE ANALYZER |
| 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 | JIL |
| Subsequent Product Code | JIO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-07-11 |
| Summary: | summary |