IQ 200 URINE ANALYZER BODY FLUIDS MODULE— 510(k) K050235

Name: FDA 510(k) clearance K050235
Creator: U.S. Food and Drug Administration
Published: 2005-03-23

Substantially Equivalent

Iris International, Inc.

FDA 510(k) clearance K050235 for IQ 200 URINE ANALYZER BODY FLUIDS MODULE, Substantially Equivalent on 2005-03-23. Applicant: Iris International, Inc.. Device class: 2.

Clearance details

Applicant: Iris International, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 2005-02-01
Decision date: 2005-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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