IL TEST UREA NITROGEN— 510(k) K974337

Name: FDA 510(k) clearance K974337
Creator: U.S. Food and Drug Administration
Published: 1997-12-17

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K974337 for IL TEST UREA NITROGEN, Substantially Equivalent on 1997-12-17. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1997-11-18
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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