NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

IRIS MOLECULAR DIAGNOSTICS

The following data is part of a premarket notification filed by Iris Molecular Diagnostics with the FDA for Nucleic Acid Detection Immunoassay (nadia) Psa Assay.

Pre-market Notification Details

Device IDK101185
510k NumberK101185
Device Name:NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
ClassificationProstate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
Applicant IRIS MOLECULAR DIAGNOSTICS 2075 CORTE DEL NOGAL SUITE J Carlsbad,  CA  92011
ContactRobert Klem
CorrespondentRobert Klem
IRIS MOLECULAR DIAGNOSTICS 2075 CORTE DEL NOGAL SUITE J Carlsbad,  CA  92011
Product CodeOWM  
CFR Regulation Number866.6040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-28
Decision Date2011-09-20
Summary:summary

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