IMMUNALYSIS COCAINE ELISA FOR HAIR— 510(k) K050465

Name: FDA 510(k) clearance K050465
Creator: U.S. Food and Drug Administration
Published: 2005-08-04

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K050465 for IMMUNALYSIS COCAINE ELISA FOR HAIR, Substantially Equivalent on 2005-08-04. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2005-03-03
Decision date: 2005-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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