Cleared Special

K994236 - AT HOME DRUG TEST, MODEL 9133

K994236 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Dec 1999
Decision
14d
Days
-
Risk

K994236 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9133. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 30, 1999 after a review of 14 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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FDA 510(k) Submission Details - K994236

510(k) Number K994236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1999
Decision Date December 30, 1999
Days to Decision 14 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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