Cleared Special

AT HOME DRUG TEST, MODEL 9171 (K991824) - FDA 510(k) Clearance

K991824 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
15d
Days
-
Risk

K991824 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9171. Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on June 11, 1999 after a review of 15 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.

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Submission Details

510(k) Number K991824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date June 11, 1999
Days to Decision 15 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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