Cleared Traditional

URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE

K950183 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Mar 1995
Decision
62d
Days
—
Risk

About This 510(k) Submission

K950183 is an FDA 510(k) clearance for the URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE, a Enzyme Immunoassay, Phencyclidine, submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 20, 1995, 62 days after receiving the submission on January 17, 1995. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K950183 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1995
Decision Date March 20, 1995
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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