The following data is part of a premarket notification filed by Iris International, Inc. with the FDA for Iq 200 Urine Analyzer Body Fluids Module.
| Device ID | K050235 |
| 510k Number | K050235 |
| Device Name: | IQ 200 URINE ANALYZER BODY FLUIDS MODULE |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth, CA 91311 |
| Contact | Harvey L Kasdan |
| Correspondent | Harvey L Kasdan IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth, CA 91311 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-01 |
| Decision Date | 2005-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10837461002475 | K050235 | 000 |