FIAX TEST KIT FOR TOBRAMYCIN QUANTITA— 510(k) K801308

Name: FDA 510(k) clearance K801308
Creator: U.S. Food and Drug Administration
Published: 1980-06-20

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K801308 for FIAX TEST KIT FOR TOBRAMYCIN QUANTITA, Substantially Equivalent on 1980-06-20. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code LCR
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1980-06-03
Decision date: 1980-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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