Cleared Traditional

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT

K911153 · Immunotech Corp. · Toxicology
Jun 1991
Decision
95d
Days
—
Risk

About This 510(k) Submission

K911153 is an FDA 510(k) clearance for the MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT, a Enzyme Immunoassay, Phencyclidine, submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on June 18, 1991, 95 days after receiving the submission on March 15, 1991. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K911153 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1991
Decision Date June 18, 1991
Days to Decision 95 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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