SEFRIA Hydrocodone Oral Fluid— 510(k) K252520

Name: FDA 510(k) clearance K252520
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K252520 for SEFRIA Hydrocodone Oral Fluid, Substantially Equivalent on 2025-09-11. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2025-08-11
Decision date: 2025-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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