SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

Enzyme Immunoassay, Opiates

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Sefria Oxycodone Oral Fluid Enzyme Immunoassay.

Pre-market Notification Details

Device IDK203564
510k NumberK203564
Device Name:SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
ClassificationEnzyme Immunoassay, Opiates
Applicant Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
ContactWenying (jessica) Zhu
CorrespondentElina Arroyo
Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-12-22

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