Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062

FDA 510(k) K033566 · Rapid Diagnostics, Inc.

Substantially Equivalent

510(k) numberK033566

Submission

Device name
Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062
Applicant
Rapid Diagnostics, Inc.
Northridge, CA, US
Received
November 12, 2003
Decision date
May 17, 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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Questions and answers

When was Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062 cleared by the FDA?

Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062 (K033566) received a 510(k) decision of Substantially Equivalent on May 17, 2004, 187 days after the submission was received.

What is the product code of K033566?

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