Cleared Special

K013410 - AT HOME DRUG TEST, MODEL 9064 (FDA 510(k) Clearance)

K013410 · Phamatech, Inc. · Toxicology device
Dec 2001
Decision
52d
Days
-
Risk

K013410 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9064. Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K013410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 06, 2001
Days to Decision 52 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 146d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class -