The following data is part of a premarket notification filed by Arj Medical, Inc. with the FDA for Uritest 50 And Uritest 500 Urine Analyzer.
| Device ID | K091472 |
| 510k Number | K091472 |
| Device Name: | URITEST 50 AND URITEST 500 URINE ANALYZER |
| Classification | Automated Urinalysis System |
| Applicant | ARJ MEDICAL, INC. 209 STATE STREET Oldsmar, FL 34677 |
| Contact | Aaron Behar |
| Correspondent | Aaron Behar ARJ MEDICAL, INC. 209 STATE STREET Oldsmar, FL 34677 |
| 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 | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2010-04-27 |
| Summary: | summary |