The following data is part of a premarket notification filed by Iris Diagnostics with the FDA for Iq 200 Urine Analizer Body Fluids Module.
| Device ID | K091539 |
| 510k Number | K091539 |
| Device Name: | IQ 200 URINE ANALIZER BODY FLUIDS MODULE |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | IRIS DIAGNOSTICS 9172 ETON AVE. Chatsworth, CA 91311 |
| Contact | William M Dougherty |
| Correspondent | William M Dougherty IRIS DIAGNOSTICS 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 | 2009-05-26 |
| Decision Date | 2010-08-31 |
| Summary: | summary |