Cleared Traditional

URINE CHEMISTRY ANALYZER UR-50

K063390 · Ind Diagnostic, Inc. · Chemistry
Mar 2007
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K063390 is an FDA 510(k) clearance for the URINE CHEMISTRY ANALYZER UR-50, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Ind Diagnostic, Inc. (Altamonte Springs, US). The FDA issued a Cleared decision on March 1, 2007, 112 days after receiving the submission on November 9, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K063390 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2006
Decision Date March 01, 2007
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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