URINE CHEMISTRY ANALYZER UR-50— 510(k) K063390

Name: FDA 510(k) clearance K063390
Creator: U.S. Food and Drug Administration
Published: 2007-03-01

Substantially Equivalent

Ind Diagnostic, Inc.

FDA 510(k) clearance K063390 for URINE CHEMISTRY ANALYZER UR-50, Substantially Equivalent on 2007-03-01. Applicant: Ind Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Ind Diagnostic, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2006-11-09
Decision date: 2007-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altamonte Springs, FL, US

Download summary PDF View on FDA.gov ↗

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