Cleared Traditional

DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL

K952412 · Dupont Medical Products · Toxicology
Jun 1995
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K952412 is an FDA 510(k) clearance for the DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Dupont Medical Products (Newark, US). The FDA issued a Cleared decision on June 23, 1995, 31 days after receiving the submission on May 23, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K952412 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1995
Decision Date June 23, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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