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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, methadone
510(k) Number K151395
Device Name Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
Applicant
Immunalysis Corporation
829 Towne Center Drive
Pomona,  CA  91767
Applicant Contact Joseph Ginete
Correspondent
Immunalysis Corporation
829 Towne Center Drive
Pomona,  CA  91767
Correspondent Contact Joseph Ginete
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Codes
DLJ   LAS  
Date Received05/26/2015
Decision Date 07/24/2015
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
Recalls CDRH Recalls
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