Submission Details
| 510(k) Number | K091539 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 26, 2009 |
| Decision Date | August 31, 2010 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
Aug 2010
Decision
462d
Days
Class 2
Risk
About This 510(k) Submission
K091539 is an FDA 510(k) clearance for the IQ 200 URINE ANALIZER BODY FLUIDS MODULE, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Iris Diagnostics (Chatsworth, US). The FDA issued a Cleared decision on August 31, 2010, 462 days after receiving the submission on May 26, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.
Device Classification
| Product Code | GKL — Counter, Cell, Automated (particle Counter) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5200 |
Manufacturer
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