IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO— 510(k) K864512

Name: FDA 510(k) clearance K864512
Creator: U.S. Food and Drug Administration
Published: 1987-02-13

Substantially Equivalent

Cooper Biomedical, Inc.

FDA 510(k) clearance K864512 for IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO, Substantially Equivalent on 1987-02-13. Applicant: Cooper Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Biomedical, Inc.
Product code: Code DAD
Device class: Class 2
Regulation: 21 CFR 866.5460
Advisory panel: Immunology
Date received: 1986-11-13
Decision date: 1987-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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