FIAX TEST KIT FOR GENTAMICIN QUAN.— 510(k) K800032

Name: FDA 510(k) clearance K800032
Creator: U.S. Food and Drug Administration
Published: 1980-01-23

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K800032 for FIAX TEST KIT FOR GENTAMICIN QUAN., Substantially Equivalent on 1980-01-23. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code LCQ
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1980-01-07
Decision date: 1980-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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