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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 K141406
Device Name IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
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
DLJ   LAS  
Date Received05/28/2014
Decision Date 07/01/2014
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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