ACA (R) DIGITOXIN CALIBRATOR— 510(k) K891093

Name: FDA 510(k) clearance K891093
Creator: U.S. Food and Drug Administration
Published: 1989-04-26

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K891093 for ACA (R) DIGITOXIN CALIBRATOR, Substantially Equivalent on 1989-04-26. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DCJ
Device class: Class 1
Regulation: 21 CFR 866.5160
Advisory panel: Immunology
Date received: 1989-03-02
Decision date: 1989-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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