GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM— 510(k) K991156

Name: FDA 510(k) clearance K991156
Creator: U.S. Food and Drug Administration
Published: 1999-05-28

Substantially Equivalent

Great Smokies Diagnostic Laboratory

FDA 510(k) clearance K991156 for GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM, Substantially Equivalent on 1999-05-28. Applicant: Great Smokies Diagnostic Laboratory. Device class: 1.

Clearance details

Applicant: Great Smokies Diagnostic Laboratory
Product code: Code JOC
Device class: Class 1
Regulation: 21 CFR 862.1820
Advisory panel: Clinical Chemistry
Date received: 1999-04-07
Decision date: 1999-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Asheville, NC, US

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