IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS— 510(k) K051578

Name: FDA 510(k) clearance K051578
Creator: U.S. Food and Drug Administration
Published: 2005-11-18

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K051578 for IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS, Substantially Equivalent on 2005-11-18. 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: 2005-06-14
Decision date: 2005-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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