IL TOBRAMYCIN ASSAY— 510(k) K903192

Name: FDA 510(k) clearance K903192
Creator: U.S. Food and Drug Administration
Published: 1990-08-22

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K903192 for IL TOBRAMYCIN ASSAY, Substantially Equivalent on 1990-08-22. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1990-07-19
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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K893913 — TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD1989-08-21

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