Cleared Special

QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178

K993165 · Phamatech · Toxicology
Oct 1999
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K993165 is an FDA 510(k) clearance for the QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on October 20, 1999, 28 days after receiving the submission on September 22, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K993165 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1999
Decision Date October 20, 1999
Days to Decision 28 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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