Cleared Traditional

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

K203564 · Immunalysis Corporation · Toxicology
Dec 2021
Decision
380d
Days
Class 2
Risk

About This 510(k) Submission

K203564 is an FDA 510(k) clearance for the SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on December 22, 2021, 380 days after receiving the submission on December 7, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K203564 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2020
Decision Date December 22, 2021
Days to Decision 380 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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