MICROMEDIC FERRITIN IRMA KIT— 510(k) K883746

Name: FDA 510(k) clearance K883746
Creator: U.S. Food and Drug Administration
Published: 1988-10-27

Substantially Equivalent

Icn Micromedic Systems

FDA 510(k) clearance K883746 for MICROMEDIC FERRITIN IRMA KIT, Substantially Equivalent on 1988-10-27. Applicant: Icn Micromedic Systems. Device class: 2.

Clearance details

Applicant: Icn Micromedic Systems
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1988-09-01
Decision date: 1988-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

Download summary PDF View on FDA.gov ↗

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