DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)— 510(k) K033851

Name: FDA 510(k) clearance K033851
Creator: U.S. Food and Drug Administration
Published: 2004-03-02

Substantially Equivalent

Hypoguard USA, Inc.

FDA 510(k) clearance K033851 for DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G), Substantially Equivalent on 2004-03-02. Applicant: Hypoguard USA, Inc.. Device class: 2.

Clearance details

Applicant: Hypoguard USA, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2003-12-11
Decision date: 2004-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

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