Varian, Inc. Ontrak Testcup and Ontrak Teststik

FDA 510(k) K033659 · Varian, Inc.

Substantially Equivalent

510(k) numberK033659

Submission

Device name
Varian, Inc. Ontrak Testcup and Ontrak Teststik
Applicant
Varian, Inc.
Lake Forest, CA, US
Received
November 21, 2003
Decision date
January 6, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DKZ – Enzyme Immunoassay, Amphetamine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3100
Specialty
Clinical Toxicology

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More from Alfa Scientific Designs, Inc.

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K060896Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional 06/09/2006SE
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Questions and answers

When was Varian, Inc. Ontrak Testcup and Ontrak Teststik cleared by the FDA?

Varian, Inc. Ontrak Testcup and Ontrak Teststik (K033659) received a 510(k) decision of Substantially Equivalent on January 6, 2004, 46 days after the submission was received.

What is the product code of K033659?

The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.