Cleared Special

QUICKSCREEN, MODELS 9177X AND 9178X

K041578 · Phamatech · Chemistry
Sep 2004
Decision
88d
Days
—
Risk

About This 510(k) Submission

K041578 is an FDA 510(k) clearance for the QUICKSCREEN, MODELS 9177X AND 9178X, a Enzyme Immunoassay, Phencyclidine, submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on September 10, 2004, 88 days after receiving the submission on June 14, 2004. This device falls under the Chemistry review panel.

Submission Details

510(k) Number K041578 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2004
Decision Date September 10, 2004
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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