Cleared Traditional

SEFRIA? Hydrocodone Oral Fluid

K252520 · Immunalysis Corporation · Toxicology
Sep 2025
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K252520 is an FDA 510(k) clearance for the SEFRIA? Hydrocodone Oral Fluid, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on September 11, 2025, 31 days after receiving the submission on August 11, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K252520 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2025
Decision Date September 11, 2025
Days to Decision 31 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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