The following data is part of a premarket notification filed by Asymmetrx with the FDA for Prostate-63 Cancer Diagnostic Test.
| Device ID | K050063 |
| 510k Number | K050063 |
| Device Name: | PROSTATE-63 CANCER DIAGNOSTIC TEST |
| Classification | Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells |
| Applicant | ASYMMETRX 117 SENATE BROOK DR. Amston, CT 06231 |
| Contact | Maria Mckeon |
| Correspondent | Maria Mckeon ASYMMETRX 117 SENATE BROOK DR. Amston, CT 06231 |
| Product Code | NTR |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-11 |
| Decision Date | 2005-02-09 |
| Summary: | summary |