VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK— 510(k) K033659

Name: FDA 510(k) clearance K033659
Creator: U.S. Food and Drug Administration
Published: 2004-01-06

Substantially Equivalent

Varian, Inc.

FDA 510(k) clearance K033659 for VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK, Substantially Equivalent on 2004-01-06. Applicant: Varian, Inc.. Device class: 2.

Clearance details

Applicant: Varian, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2003-11-21
Decision date: 2004-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.