ANTINUCLEAR ANTIBODY SCREEN FLOURESC— 510(k) K821576

Name: FDA 510(k) clearance K821576
Creator: U.S. Food and Drug Administration
Published: 1982-06-10

Substantially Equivalent

Immuno-Products Industries

FDA 510(k) clearance K821576 for ANTINUCLEAR ANTIBODY SCREEN FLOURESC, Substantially Equivalent on 1982-06-10. Applicant: Immuno-Products Industries. Device class: 2.

Clearance details

Applicant: Immuno-Products Industries
Product code: Code DBL
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1982-05-28
Decision date: 1982-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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