HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT— 510(k) K944876

Name: FDA 510(k) clearance K944876
Creator: U.S. Food and Drug Administration
Published: 1994-12-15

Substantially Equivalent

Research Diagnostics, Inc.

FDA 510(k) clearance K944876 for HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT, Substantially Equivalent on 1994-12-15. Applicant: Research Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Research Diagnostics, Inc.
Product code: Code DAS
Device class: Class 1
Regulation: 21 CFR 866.5530
Advisory panel: Immunology
Date received: 1994-10-03
Decision date: 1994-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flanders, NJ, US

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