Cleared Traditional

ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)

K040327 · Accu-Stat Diagnostics, Inc. · Toxicology
Apr 2004
Decision
69d
Days
—
Risk

About This 510(k) Submission

K040327 is an FDA 510(k) clearance for the ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC), a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, submitted by Accu-Stat Diagnostics, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 19, 2004, 69 days after receiving the submission on February 10, 2004. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K040327 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2004
Decision Date April 19, 2004
Days to Decision 69 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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