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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K203527
Device Name Immunalysis Tapentadol Urine HEIA
Applicant
Lmmunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact Elina Arroyo
Correspondent
Lmmunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact Elina Arroyo
Regulation Number862.3650
Classification Product Code
DJG  
Date Received12/02/2020
Decision Date 05/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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