IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY— 510(k) K141803

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K141803 for IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY, Substantially Equivalent on 2015-02-12. Applicant: Immunalysis Corporation.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2014-07-03
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

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