BECKMAN EPSILON(TM) FERRITIN TEST KIT— 510(k) K864437

Name: FDA 510(k) clearance K864437
Creator: U.S. Food and Drug Administration
Published: 1987-01-16

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K864437 for BECKMAN EPSILON(TM) FERRITIN TEST KIT, Substantially Equivalent on 1987-01-16. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1986-11-12
Decision date: 1987-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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