Cleared Traditional

SEFRIA PCP Oral Fluid Enzyme Immunoassay

K203489 · Immunalysis Corporation · Toxicology
Apr 2021
Decision
144d
Days
—
Risk

About This 510(k) Submission

K203489 is an FDA 510(k) clearance for the SEFRIA PCP Oral Fluid Enzyme Immunoassay, a Enzyme Immunoassay, Phencyclidine, submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on April 20, 2021, 144 days after receiving the submission on November 27, 2020. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K203489 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2020
Decision Date April 20, 2021
Days to Decision 144 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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