ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.— 510(k) K800206

Name: FDA 510(k) clearance K800206
Creator: U.S. Food and Drug Administration
Published: 1980-03-03

Substantially Equivalent

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

FDA 510(k) clearance K800206 for ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT., Substantially Equivalent on 1980-03-03. 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: 1980-01-30
Decision date: 1980-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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