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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
510(k) Number K101185
Device Name NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
Applicant
IRIS MOLECULAR DIAGNOSTICS
2075 CORTE DEL NOGAL
SUITE J
CARLSBAD,  CA  92011
Applicant Contact ROBERT KLEM
Correspondent
IRIS MOLECULAR DIAGNOSTICS
2075 CORTE DEL NOGAL
SUITE J
CARLSBAD,  CA  92011
Correspondent Contact ROBERT KLEM
Regulation Number866.6040
Classification Product Code
OWM  
Date Received04/28/2010
Decision Date 09/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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