RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN— 510(k) K851283

Name: FDA 510(k) clearance K851283
Creator: U.S. Food and Drug Administration
Published: 1985-05-23

Substantially Equivalent

Cooper Biomedical, Inc.

FDA 510(k) clearance K851283 for RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN, Substantially Equivalent on 1985-05-23. Applicant: Cooper Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Biomedical, Inc.
Product code: Code DDB
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Date received: 1985-04-01
Decision date: 1985-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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