DeviceClearance

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators— 510(k) K161216

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K161216 for Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators, Substantially Equivalent on 2017-06-14. Applicant: Immunalysis Corporation.

Clearance details

Applicant
Immunalysis Corporation
Product code
Code DJG
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pomona, CA, US
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