ACE ALBUMIN CALIBRATOR— 510(k) K821061

Name: FDA 510(k) clearance K821061
Creator: U.S. Food and Drug Administration
Published: 1982-05-03

Substantially Equivalent

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

FDA 510(k) clearance K821061 for ACE ALBUMIN CALIBRATOR, Substantially Equivalent on 1982-05-03. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1982-04-15
Decision date: 1982-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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