Cleared Traditional

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

K181135 · Immunalysis Corporation · Toxicology
Jan 2019
Decision
269d
Days
—
Risk

About This 510(k) Submission

K181135 is an FDA 510(k) clearance for the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay, a Enzyme Immunoassay, Phencyclidine, submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on January 24, 2019, 269 days after receiving the submission on April 30, 2018. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K181135 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2018
Decision Date January 24, 2019
Days to Decision 269 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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