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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
510(k) Number K050063
Device Name PROSTATE-63 CANCER DIAGNOSTIC TEST
Applicant
Asymmetrx
117 Senate Brook Dr.
Amston,  CT  06231
Applicant Contact MARIA MCKEON
Correspondent
Asymmetrx
117 Senate Brook Dr.
Amston,  CT  06231
Correspondent Contact MARIA MCKEON
Regulation Number864.1860
Classification Product Code
NTR  
Date Received01/11/2005
Decision Date 02/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
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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