IL TEST GENTAMICIN CALIBRATORS— 510(k) K943982

Name: FDA 510(k) clearance K943982
Creator: U.S. Food and Drug Administration
Published: 1995-01-25

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K943982 for IL TEST GENTAMICIN CALIBRATORS, Substantially Equivalent on 1995-01-25. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1994-06-07
Decision date: 1995-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.