LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR— 510(k) K033899

Name: FDA 510(k) clearance K033899
Creator: U.S. Food and Drug Administration
Published: 2004-05-20

Substantially Equivalent

Lifestream Technologies, Inc.

FDA 510(k) clearance K033899 for LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR, Substantially Equivalent on 2004-05-20. Applicant: Lifestream Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Lifestream Technologies, Inc.
Product code: Code NFX
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2003-12-17
Decision date: 2004-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Post Falls, ID, US

Download summary PDF View on FDA.gov ↗

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