VAP-NT CHOLESTEROL TEST— 510(k) K062026

Substantially Equivalent

Atherotech, Inc.

FDA 510(k) clearance K062026 for VAP-NT CHOLESTEROL TEST, Substantially Equivalent on 2007-03-06. Applicant: Atherotech, Inc.. Device class: 1.

Clearance details

Applicant: Atherotech, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2006-07-18
Decision date: 2007-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, US

Download summary PDF View on FDA.gov ↗

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