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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 K143502
Device Name Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
Applicant
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact JOSEPH GINETE
Correspondent
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact JOSEPH GINETE
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIF   DLJ  
Date Received12/10/2014
Decision Date 05/20/2015
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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