SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay— 510(k) K203564

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K203564 for SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay, Substantially Equivalent on 2021-12-22. 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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