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 |