ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)— 510(k) K981181

Name: FDA 510(k) clearance K981181
Creator: U.S. Food and Drug Administration
Published: 1998-08-03

Substantially Equivalent

Actimed Laboratories, Inc.

FDA 510(k) clearance K981181 for ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE), Substantially Equivalent on 1998-08-03. 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: 1998-04-01
Decision date: 1998-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, NJ, US

Download summary PDF View on FDA.gov ↗

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