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 Number | 866.6040
|
Classification Product Code |
|
Date Received | 04/28/2010 |
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
|