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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, Benzodiazepine
510(k) Number K151771
Device Name Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug 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 Number862.3170
Classification Product Code
JXM  
Subsequent Product Code
DKB  
Date Received06/30/2015
Decision Date 01/05/2016
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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