CHOLESTRON PRO II CHOLESTEROL TEST— 510(k) K981345

Name: FDA 510(k) clearance K981345
Creator: U.S. Food and Drug Administration
Published: 1998-10-01

Substantially Equivalent

Lifestream Diagnostics, Inc.

FDA 510(k) clearance K981345 for CHOLESTRON PRO II CHOLESTEROL TEST, Substantially Equivalent on 1998-10-01. Applicant: Lifestream Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Lifestream Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1998-04-14
Decision date: 1998-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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