LYOPHILIZED HDL CHOLESTEROL CONTROLS— 510(k) K792025

Name: FDA 510(k) clearance K792025
Creator: U.S. Food and Drug Administration
Published: 1979-10-30

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K792025 for LYOPHILIZED HDL CHOLESTEROL CONTROLS, Substantially Equivalent on 1979-10-30. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1979-10-09
Decision date: 1979-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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