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.
Device ID | K101185 |
510k Number | K101185 |
Device Name: | NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY |
Classification | Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers |
Applicant | IRIS MOLECULAR DIAGNOSTICS 2075 CORTE DEL NOGAL SUITE J Carlsbad, CA 92011 |
Contact | Robert Klem |
Correspondent | Robert Klem IRIS MOLECULAR DIAGNOSTICS 2075 CORTE DEL NOGAL SUITE J Carlsbad, CA 92011 |
Product Code | OWM |
CFR Regulation Number | 866.6040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-28 |
Decision Date | 2011-09-20 |
Summary: | summary |