STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS— 510(k) K030650

Name: FDA 510(k) clearance K030650
Creator: U.S. Food and Drug Administration
Published: 2003-04-14

Substantially Equivalent

Uridynamics, Inc.

FDA 510(k) clearance K030650 for STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS, Substantially Equivalent on 2003-04-14. Applicant: Uridynamics, Inc.. Device class: 1.

Clearance details

Applicant: Uridynamics, Inc.
Product code: Code CEN
Device class: Class 1
Regulation: 21 CFR 862.1550
Advisory panel: Clinical Chemistry
Date received: 2003-02-28
Decision date: 2003-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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