IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT— 510(k) K863868

Name: FDA 510(k) clearance K863868
Creator: U.S. Food and Drug Administration
Published: 1987-02-13

Substantially Equivalent

Cooper Biomedical, Inc.

FDA 510(k) clearance K863868 for IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT, Substantially Equivalent on 1987-02-13. Applicant: Cooper Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Biomedical, Inc.
Product code: Code DFF
Device class: Class 2
Regulation: 21 CFR 866.5080
Advisory panel: Immunology
Date received: 1986-10-03
Decision date: 1987-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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