ONTRAK TESTCARD 9— 510(k) K050321

Substantially Equivalent

Varian, Inc.

FDA 510(k) clearance K050321 for ONTRAK TESTCARD 9, Substantially Equivalent on 2005-04-18. Applicant: Varian, Inc.. Device class: 2.

Clearance details

Applicant: Varian, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2005-02-09
Decision date: 2005-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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