RESOLUTION CHOLESTEROL MONITOR— 510(k) K000610

Name: FDA 510(k) clearance K000610
Creator: U.S. Food and Drug Administration
Published: 2000-07-21

Substantially Equivalent

Lifestream Technologies, Inc.

FDA 510(k) clearance K000610 for RESOLUTION CHOLESTEROL MONITOR, Substantially Equivalent on 2000-07-21. Applicant: Lifestream Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Lifestream Technologies, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2000-02-23
Decision date: 2000-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Post Falls, ID, US

Download summary PDF View on FDA.gov ↗

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