CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS— 510(k) K052525

Name: FDA 510(k) clearance K052525
Creator: U.S. Food and Drug Administration
Published: 2006-03-29

Substantially Equivalent

DFI Co., Ltd.

FDA 510(k) clearance K052525 for CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS, Substantially Equivalent on 2006-03-29. Applicant: DFI Co., Ltd.. Device class: 2.

Clearance details

Applicant: DFI Co., Ltd.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2005-09-14
Decision date: 2006-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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