TEST, DETECTION, ANTINUCLEAR ANTIBODIES— 510(k) K760206

Name: FDA 510(k) clearance K760206
Creator: U.S. Food and Drug Administration
Published: 1976-08-03

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K760206 for TEST, DETECTION, ANTINUCLEAR ANTIBODIES, Substantially Equivalent on 1976-08-03. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1976-07-09
Decision date: 1976-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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