Innovacon Spectrum II Test Card

FDA 510(k) K061718 · Innovacon, Inc.

Substantially Equivalent

510(k) numberK061718

Submission

Device name
Innovacon Spectrum II Test Card
Applicant
Innovacon, Inc.
San Diego, CA, US
Received
June 19, 2006
Decision date
November 13, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary 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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Questions and answers

When was Innovacon Spectrum II Test Card cleared by the FDA?

Innovacon Spectrum II Test Card (K061718) received a 510(k) decision of Substantially Equivalent on November 13, 2006, 147 days after the submission was received.

What is the product code of K061718?

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