ON TRAK TESTCARD— 510(k) K051235

Substantially Equivalent

Varian, Inc.

FDA 510(k) clearance K051235 for ON TRAK TESTCARD, Substantially Equivalent on 2005-06-08. 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: 2005-05-13
Decision date: 2005-06-08
Decision: Substantially Equivalent
Clearance type: Special
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.