The following data is part of a premarket notification filed by Iris Diagnostics, A Division Of Iris International Inc with the FDA for Ichemvelocity Automated Urine Chemistry System.
| Device ID | K171083 |
| 510k Number | K171083 |
| Device Name: | IChemVELOCITY Automated Urine Chemistry System |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | Iris Diagnostics, A Division Of Iris International Inc 9172 Eton Avenue Chatsworth, CA 91311 |
| Contact | Nancy Nadler |
| Correspondent | Nancy Nadler Iris Diagnostics, A Division Of Iris International Inc 9172 Eton Avenue Chatsworth, CA 91311 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-11 |
| Decision Date | 2017-05-12 |
| Summary: | summary |