URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS— 510(k) K040703

Name: FDA 510(k) clearance K040703
Creator: U.S. Food and Drug Administration
Published: 2004-08-26

Substantially Equivalent

Dirui Industrial Co., Ltd.

FDA 510(k) clearance K040703 for URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS, Substantially Equivalent on 2004-08-26. Applicant: Dirui Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dirui Industrial Co., Ltd.
Product code: Code JIO
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2004-03-17
Decision date: 2004-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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