Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators— 510(k) K161216

Name: FDA 510(k) clearance K161216
Creator: U.S. Food and Drug Administration
Published: 2017-06-14

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K161216 for Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators, Substantially Equivalent on 2017-06-14. 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: 2016-04-29
Decision date: 2017-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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