IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY— 510(k) K131168

Name: FDA 510(k) clearance K131168
Creator: U.S. Food and Drug Administration
Published: 2014-01-17

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K131168 for IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY, Substantially Equivalent on 2014-01-17. 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: 2013-04-24
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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