LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS— 510(k) K120763

Name: FDA 510(k) clearance K120763
Creator: U.S. Food and Drug Administration
Published: 2012-06-01

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K120763 for LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS, Substantially Equivalent on 2012-06-01. Applicant: Lin-Zhi International, Inc.. Device class: 2.

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2012-03-13
Decision date: 2012-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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