LYPOPROTEIN CHOLESTEROL TEST KIT— 510(k) K780173

Name: FDA 510(k) clearance K780173
Creator: U.S. Food and Drug Administration
Published: 1978-05-03

Substantially Equivalent

Environmental Chemical Specialties

FDA 510(k) clearance K780173 for LYPOPROTEIN CHOLESTEROL TEST KIT, Substantially Equivalent on 1978-05-03. Applicant: Environmental Chemical Specialties. Device class: 1.

Clearance details

Applicant: Environmental Chemical Specialties
Product code: Code JHM
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1978-02-02
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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