Cleared Special

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

K011161 · Syva Co., Dade Behring, Inc. · Toxicology
May 2001
Decision
29d
Days
—
Risk

About This 510(k) Submission

K011161 is an FDA 510(k) clearance for the MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229, a Enzyme Immunoassay, Phencyclidine, submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 15, 2001, 29 days after receiving the submission on April 16, 2001. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K011161 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2001
Decision Date May 15, 2001
Days to Decision 29 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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