The following data is part of a premarket notification filed by Iris International, Inc. with the FDA for Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle.
| Device ID | K093861 |
| 510k Number | K093861 |
| Device Name: | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE |
| Classification | Counter, Urine Particle |
| Applicant | IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth, CA 91311 |
| Contact | Ellen Johnston |
| Correspondent | Ellen Johnston IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth, CA 91311 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-02-05 |
| Summary: | summary |