ENA-C-T TOTAL CHOLESTEROL TEST— 510(k) K960377

Name: FDA 510(k) clearance K960377
Creator: U.S. Food and Drug Administration
Published: 1996-05-02

Substantially Equivalent

Actimed Laboratories, Inc.

FDA 510(k) clearance K960377 for ENA-C-T TOTAL CHOLESTEROL TEST, Substantially Equivalent on 1996-05-02. Applicant: Actimed Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Actimed Laboratories, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1996-01-26
Decision date: 1996-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, NJ, US

Download summary PDF View on FDA.gov ↗

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