URITEST 10 URINALYSIS REAGENT STRIPS— 510(k) K052719

Name: FDA 510(k) clearance K052719
Creator: U.S. Food and Drug Administration
Published: 2006-12-05

Substantially Equivalent

Arj Medical, Inc.

FDA 510(k) clearance K052719 for URITEST 10 URINALYSIS REAGENT STRIPS, Substantially Equivalent on 2006-12-05. Applicant: Arj Medical, Inc.. Device class: 1.

Clearance details

Applicant: Arj Medical, Inc.
Product code: Code CDM
Device class: Class 1
Regulation: 21 CFR 862.1785
Advisory panel: Clinical Chemistry
Date received: 2005-09-29
Decision date: 2006-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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