FIAX TEST KIT FOR THEOPHYLLINE QUANT.— 510(k) K801642

Name: FDA 510(k) clearance K801642
Creator: U.S. Food and Drug Administration
Published: 1980-08-27

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K801642 for FIAX TEST KIT FOR THEOPHYLLINE QUANT., Substantially Equivalent on 1980-08-27. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1980-07-17
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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