URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM— 510(k) K013819

Name: FDA 510(k) clearance K013819
Creator: U.S. Food and Drug Administration
Published: 2002-02-28

Substantially Equivalent

Sierra Diagnostic, LLC

FDA 510(k) clearance K013819 for URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM, Substantially Equivalent on 2002-02-28. Applicant: Sierra Diagnostic, LLC. Device class: 1.

Clearance details

Applicant: Sierra Diagnostic, LLC
Product code: Code JTW
Device class: Class 1
Regulation: 21 CFR 866.2900
Advisory panel: Microbiology
Date received: 2001-11-16
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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