Cleared Special

QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04

K000131 · Phamatech · Toxicology
Feb 2000
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K000131 is an FDA 510(k) clearance for the QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on February 4, 2000, 17 days after receiving the submission on January 18, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K000131 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2000
Decision Date February 04, 2000
Days to Decision 17 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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