WAKO HDL CHOLESTEROL TEST— 510(k) K801834

Name: FDA 510(k) clearance K801834
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Wako Pure Chemical Industries, Ltd.

FDA 510(k) clearance K801834 for WAKO HDL CHOLESTEROL TEST, Substantially Equivalent on 1980-09-16. Applicant: Wako Pure Chemical Industries, Ltd.. Device class: 1.

Clearance details

Applicant: Wako Pure Chemical Industries, Ltd.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1980-08-01
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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