Cleared Traditional

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

K203647 · Immunalysis Corporation · Toxicology
Dec 2021
Decision
373d
Days
Class 2
Risk

About This 510(k) Submission

K203647 is an FDA 510(k) clearance for the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on December 22, 2021, 373 days after receiving the submission on December 14, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K203647 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2020
Decision Date December 22, 2021
Days to Decision 373 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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