FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST— 510(k) K013263

Name: FDA 510(k) clearance K013263
Creator: U.S. Food and Drug Administration
Published: 2002-07-29

Substantially Equivalent

Fred Hutchinson Cancer Research Center

FDA 510(k) clearance K013263 for FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST, Substantially Equivalent on 2002-07-29. Applicant: Fred Hutchinson Cancer Research Center. Device class: 2.

Clearance details

Applicant: Fred Hutchinson Cancer Research Center
Product code: Code LKP
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2001-10-01
Decision date: 2002-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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