The following data is part of a premarket notification filed by Iris International Inc., A Division Of Iris Iris I with the FDA for Chem Velocity Automated Urine Chemistry System, Strips And Calchek Kit.
| Device ID | K101852 |
| 510k Number | K101852 |
| Device Name: | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT |
| Classification | Automated Urinalysis System |
| Applicant | IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I 9172 ETON AVENUE Chatsworth, CA 91311 |
| Contact | David W Gates |
| Correspondent | David W Gates IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I 9172 ETON AVENUE Chatsworth, CA 91311 |
| 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 | JMA |
| 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 | 2010-07-01 |
| Decision Date | 2011-03-23 |
| Summary: | summary |