IQ 200 URINE ANALIZER BODY FLUIDS MODULE— 510(k) K091539

Name: FDA 510(k) clearance K091539
Creator: U.S. Food and Drug Administration
Published: 2010-08-31

Substantially Equivalent

Iris Diagnostics

FDA 510(k) clearance K091539 for IQ 200 URINE ANALIZER BODY FLUIDS MODULE, Substantially Equivalent on 2010-08-31. Applicant: Iris Diagnostics. Device class: 2.

Clearance details

Applicant: Iris Diagnostics
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 2009-05-26
Decision date: 2010-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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