FIAX 100 FLUOROMETER— 510(k) K843356

Name: FDA 510(k) clearance K843356
Creator: U.S. Food and Drug Administration
Published: 1984-09-17

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K843356 for FIAX 100 FLUOROMETER, Substantially Equivalent on 1984-09-17. Applicant: Intl. Diagnostic Technology. Device class: 1.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code JZT
Device class: Class 1
Regulation: 21 CFR 866.4520
Advisory panel: Immunology
Date received: 1984-08-27
Decision date: 1984-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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