IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL— 510(k) K854179

Name: FDA 510(k) clearance K854179
Creator: U.S. Food and Drug Administration
Published: 1985-11-25

Substantially Equivalent

Clinical Data, Inc.

FDA 510(k) clearance K854179 for IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL, Substantially Equivalent on 1985-11-25. Applicant: Clinical Data, Inc.. Device class: 1.

Clearance details

Applicant: Clinical Data, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1985-10-15
Decision date: 1985-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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