FIAX HAPTOGLOBIN TEST KIT— 510(k) K843570

Name: FDA 510(k) clearance K843570
Creator: U.S. Food and Drug Administration
Published: 1984-10-05

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K843570 for FIAX HAPTOGLOBIN TEST KIT, Substantially Equivalent on 1984-10-05. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DAB
Device class: Class 2
Regulation: 21 CFR 866.5460
Advisory panel: Immunology
Date received: 1984-09-11
Decision date: 1984-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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