The following data is part of a premarket notification filed by Arj Medical, Inc. with the FDA for Uritest 10 Urinalysis Reagent Strips.
| Device ID | K052719 |
| 510k Number | K052719 |
| Device Name: | URITEST 10 URINALYSIS REAGENT STRIPS |
| Classification | Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| 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 | 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 | 862.1785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2006-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10763924710147 | K052719 | 000 |
| 10763924410146 | K052719 | 000 |
| 10763924210142 | K052719 | 000 |