The following data is part of a premarket notification filed by Iris International, Inc. with the FDA for Ichem 100 Urine Chemistry Analyzer.
| Device ID | K060280 |
| 510k Number | K060280 |
| Device Name: | ICHEM 100 URINE CHEMISTRY ANALYZER |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth, CA 91311 |
| Contact | Gerald J Haddock |
| Correspondent | Gerald J Haddock IRIS INTERNATIONAL, INC. 9172 ETON AVE. 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 | JJQ |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| 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 | 2006-02-02 |
| Decision Date | 2006-06-13 |
| Summary: | summary |