IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS— 510(k) K141406

Name: FDA 510(k) clearance K141406
Creator: U.S. Food and Drug Administration
Published: 2014-07-01

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K141406 for IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS, Substantially Equivalent on 2014-07-01. 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: 2014-05-28
Decision date: 2014-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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