COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)— 510(k) K893419

Name: FDA 510(k) clearance K893419
Creator: U.S. Food and Drug Administration
Published: 1989-08-03

Substantially Equivalent

Coulter Immunology

FDA 510(k) clearance K893419 for COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM), Substantially Equivalent on 1989-08-03. Applicant: Coulter Immunology. Device class: 2.

Clearance details

Applicant: Coulter Immunology
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1989-05-02
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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