ALLO-TYPE HUMAN IMMUNOGLOBULIN-— 510(k) K841114

Name: FDA 510(k) clearance K841114
Creator: U.S. Food and Drug Administration
Published: 1984-06-14

Substantially Equivalent

Genetic Testing Institute

FDA 510(k) clearance K841114 for ALLO-TYPE HUMAN IMMUNOGLOBULIN-, Substantially Equivalent on 1984-06-14. Applicant: Genetic Testing Institute. Device class: 1.

Clearance details

Applicant: Genetic Testing Institute
Product code: Code DGX
Device class: Class 1
Regulation: 21 CFR 866.5065
Advisory panel: Immunology
Date received: 1984-03-15
Decision date: 1984-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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