ELISA COMBI-KIT HUMAN IGG SUBCLASSES— 510(k) K911610

Name: FDA 510(k) clearance K911610
Creator: U.S. Food and Drug Administration
Published: 1991-06-12

Substantially Equivalent

Janssen Research Foundation

FDA 510(k) clearance K911610 for ELISA COMBI-KIT HUMAN IGG SUBCLASSES, Substantially Equivalent on 1991-06-12. Applicant: Janssen Research Foundation. Device class: 2.

Clearance details

Applicant: Janssen Research Foundation
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1991-03-25
Decision date: 1991-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

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