Cleared Traditional

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM

K013819 · Sierra Diagnostic, LLC · Microbiology
Feb 2002
Decision
104d
Days
Class 1
Risk

About This 510(k) Submission

K013819 is an FDA 510(k) clearance for the URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM, a System, Transport, Aerobic (Class I — General Controls, product code JTW), submitted by Sierra Diagnostic, LLC (Washington, US). The FDA issued a Cleared decision on February 28, 2002, 104 days after receiving the submission on November 16, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K013819 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2001
Decision Date February 28, 2002
Days to Decision 104 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTW — System, Transport, Aerobic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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