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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, Phencyclidine
510(k) Number K152176
Device Name Immunalysis PCP 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
Classification Product Code
LCM  
Subsequent Product Code
DKB  
Date Received08/04/2015
Decision Date 09/04/2015
Decision Substantially Equivalent (SESE)
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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